project manager of research

Resume Builder

• Resume Experts
• Search Jobs
• Search for Talent
• Employer Branding
• Outplacement

Project Manager, Research Job Description

Project manager, research duties & responsibilities.

To write an effective project manager, research job description, begin by listing detailed duties, responsibilities and expectations. We have included project manager, research job description templates that you can modify and use.

Sample responsibilities for this position include:

Project Manager, Research Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Project Manager, Research

List any licenses or certifications required by the position: PMP, PMI, GCP, IATA, SAS, SOLE, NACE, SMRP, ASQ, CITI

Education for Project Manager, Research

Typically a job would require a certain level of education.

Employers hiring for the project manager, research job most commonly would prefer for their future employee to have a relevant degree such as Master's and Bachelor's Degree in Writing, Project Management, Public Health, Management, Social Sciences, Communication, Science, Spanish, Education, English

Skills for Project Manager, Research

Desired skills for project manager, research include:

Desired experience for project manager, research includes:

Project Manager, Research Examples

• Microsoft Word (.docx) .DOCX
• PDF Document (.pdf) .PDF
• Image File (.png) .PNG
• Works alongside Project Director and Moderator to learn how to provide design recommendations by offering thoughtful input and guidance
• Manages fieldwork by partnering with Moderator, Client and facilities/technology platforms
• Oversees the study recruitment and resolves difficulties
• Oversees finances and billing of each project while communicating costs to project stakeholders
• Participates in divisional and special interest meetings as needed to keep abreast of business process and policy changes
• Report on activities as required for divisional performance monitoring
• Documents policies and procedures
• Represents Principal Investigators at local, regional and national meetings, acting on their behalf to disseminate information, identify, advise and resolve issues involving multi-center studies
• Manages third-party partners and outsourcing vendors to deliver the highest levels of client satisfaction
• Successfully manages multiple challenging and complex projects
• Actively manage project budget, work plan, profitability, project and billings schedule
• Owns questionnaire, sample design, analysis, and reporting and serves as day-to-day client contact on projects
• Participates in the proposal development process (e.g., schedule, pricing, methodology)
• Actively manages client relationships for existing clients
• Anticipates and identifies project problems and finds solutions independently or with minimal guidance
• Presents a CMB University case study annually
• Organize and coordinate all project meetings
• Handle all project communications with partners, participants, and other stakeholders
• Lead efforts to recruit research participants
• Coordinate all human subject (IRB) processes and procedures for the project
• Write project reports, including yearly report to funding agency and schools
• Oversee project budget and work with budget office to process project payments
• Supervise and coordinate project personnel to accomplish all data collection, management, storage, and access
• Support qualitative data analysis in mathematics education
• Lead project dissemination efforts (presentations, publications, etc)
• Maintain project website
• Work with experts to set and maintain the project learning management system
• Other duties and responsibilities as assigned by the project principal investigator
• Identifies funding opportunities and serves as lead grant writer
• Convenes topic-focused faculty working groups and coordinates the work of multidisciplinary teams
• Engages institutions, agencies and potential funders in nurturing new models and solutions
• Facilitates the creation of proposals, and works strategically with faculty and external partners to develop project designs and protocols
• Compiles and summarizes research results, presents findings and writes papers for peer-reviewed journals, abstracts and presentations
• Contributes to conferences and symposia
• Effectively use Market Strategies tools and software to monitor data collection
• Perform qualitative project management tasks with guidance
• Process improvement, standardization, and tools development for key research processes
• Contract negotiation and compliance for US Government funded research projects
• Logistical and operational support for key research meetings and conferences
• Manage portfolio of externally funded projects by European Commission and other government bodies (planning, monitoring, reporting)
• Take an active part in operational and project management process improvement, standardization and tools development for key research processes
• Interface with legal, licensing and commercial fulfilment teams to ensure smooth execution of research projects and industrial & academic collaborations, and develop plan to address recurring issues
• Identifies key business opportunities and/ or issues and develop appropriate action plans
• Two to four years of clinical research project management experience, preferably in a CRO or related environment
• Knowledge of clinical research operations and data management, or experience in an equivalent regulated environment
• Familiar with GCPs and FDA regulations as they pertain to the management of clinical studies
• Demonstrated professional outlook and excellent communication skills
• Bachelor’s degree in Finance, Process Engineering, Business/Management or directly related degree required
• Develop study-specific procedures, study protocol, Case Report Forms (including testing) and other study operational documents
• Create and maintain detailed project timelines, work flows and monitor project progress to ensure milestones are met on time and within budget
• May create and/or manage research study budget which may include deciding on & approving expenditures of funds based on budget
• Trains, directs, assigns duties to & may supervise lab EEs, students, residents and/or fellows
• Performs professional work that requires specialized to general knowledge of the field of institutional research, and a solid understanding, use, and application of concepts, theories, principles, practices, and terminology of this area of specialization
• Manages institutional research workflow and provide status reports to the Vice President and the Director
• Supports the Institutional Research Office’s core activity of capturing, extracting, analyzing, and reporting data on faculty, students, staff and other critical academic, physical and financial information for leadership (university wide, chancellor, and school operations) decision-making purposes and external reporting requirements
• Creates reports, presentations, and publications based on the data analyses conducted
• Presents research findings made to university administrators
• Deadlines for research projects met within established time frames
• Academic and/or practical experience with survey or market research methodologies or operations preferred
• Must be detail-oriented, self-motivated, and possess a desire to work with data and numbers
• Demonstrate excellent interpersonal and communication skills (written and verbal) with project teams inside the company and clients outside
• Must be able to deal with ambiguity and make independent decisions about proposal content and project work
• Experience with agile project management (Scrum, Kanban ) traditional waterfall project management
• Ability and interest to master project management & collaboration tools such as Jira, Confluence, MS Project and Trello
• Collaborates with investigators on planning and implementation of statistical analyses
• Participates in implementing federally funded health services research studies and in development of publications reporting results
• Implements complex data linkages across large datasets, applies techniques such as construction of episodes of care and medication use calendars from healthcare claims data, uses advanced techniques in SAS software, and provides guidance to statistical programmers, while applying and further developing expertise in statistical modeling of outcomes
• Manage customer satisfaction tracking studies across different constituents by partnering with research suppliers
• Learn all visit study components to effectively manage the staff and quality control processes
• Use information provided by the Data Manager for operational decision making, including determining staffing patterns, developing data clean-up projects, and evaluating the efficiency of data collection activities
• Oversee scheduling of research visits with staff and participants and troubleshoot issues related to visits and participants
• Supervise 5-8 Research Assistants, in accordance with HPHCI policies
• Oversee on-boarding and training of new field staff
• Update and maintain Viva Protocol, Operations Manual and Training Manual
• Prior experience with qualitative research facilities, recruiters, or exposure to a variety of qualitative research methods is highly preferred
• Prior experience in client-facing role preferred
• Experience with REDCap, Wordpress, mHealth
• BA/BS in a biological science with significant experience of working in a Research environment and greater than 4 years’ experience in the biotechnology/pharmaceutical industry
• Advanced degree (e.g, MS with greater than two years’ experience in the industry)
• Understand the overall biologic/pharmaceutical product development process, stages of drug discovery and experience participating on a cross functional project teams

Related Job Descriptions

Create a Resume in Minutes with Professional Resume Templates

I am an Employer

I am a candidate.

Penn State Job Catalog

Research project management – manager (psu1523), additional levels.

Additional levels that exist for this job profile can be seen below.

Job Strings

The defined natural career progression within or between job profiles.

Research Project Management

Job summary.

Research Project Management Managers provide leadership of research teams including hiring, training, and evaluating staff; oversee project operations including project infrastructure, operating procedures, workflows, timelines, and deliverables; evaluate research methodologies and data management plans and make recommendations to ensure quality outcomes; administer project budget; develop strategic plans to advance research goals and promote project interests.

Representative Duties

• Lead a research team including hiring, training, mentoring, and evaluating; establish and review performance standards; provide development opportunities
• Design project work-flow processes and project infrastructure; delegate, prioritize, and review research tasks in order to achieve project goals and improve results
• Serve as point on contact and liaison with faculty, external and internal advisory boards, and regulatory agencies; interface with external collaborators to direct and facilitate multi-site and collaborative research
• Direct the standardization of procedures; establish reporting procedures and ensure reporting requirements are met
• Lead and direct special projects as requested by Institute directors; recommend and implement new initiatives aimed at expanding the research portfolio and impact
• Provide guidance and oversight of compliance with government regulations and University policies on research; keep abreast of compliance regulations and changes
• Plan and administer project budgets; serve as liaison with central financial offices including research accounting, payroll, and department financial officers; create financial and statistical reports for Principal Investigators and division/department executives; analyze information and recommend spending activity
• Collaborate with unit, department, or center leadership to develop strategic partnerships, advance the mission of research initiatives and projects; develop long term plans for resource allocation

Level Matrix

Salary structure.

• Comp Grade – 13
• Minimum – $86,300.00
• MidPoint – $107,900.00
• Maximum – $129,500.00

FLSA Exemption Status

Minimum education, minimum experience, equivalency, additional job requirements.

• Get the Job
• Resumes and CVs
• Applications
• Cover Letters
• Professional References

Professional Licenses and Exams

• Get a Promotion
• Negotiation
• Professional Ethics
• Professionalism
• Dealing with Coworkers
• Dealing with Bosses

Communication Skills

Managing the office, disabilities, harassment and discrimination, unemployment.

• Career Paths
• Compare Careers
• Switching Careers
• Training and Certifications
• Start a Company
• Internships and Apprenticeships
• Entry Level Jobs
• College Degrees

Growth Trends for Related Jobs

Research project manager job description.

Research project managers (PMs) are responsible for leading research projects to satisfy a defined business or scientific objective. To support this goal, research project managers decide on the methodology and techniques for conducting the research, and lead the development of research instruments. They are responsible for reviewing research related fieldwork, validating collected data, authoring reports and communicating across various research constituencies.

Project Management

Project managers specializing in research possess advanced program and project management skills, strong analytical abilities, and familiarity with research discovery and development processes. They coordinate and facilitate the research project management life cycle, including initiation, development, and implementation of various complex experimentation projects. They are responsible for scoping, coordinating early research activities, identifying research candidates, and managing the completion of investigational forms. Research PMs coordinate study teams, and manage research project timelines, to ensure research trials are completed within the specified timeline.

Research project managers regularly meet with stakeholders, including research constituents, clients and study teams, to collect and communicate business and research requirements, and set expectations for research-related work.

Research Management

In the context of research management--which typically includes clinical, scientific, experimental, medical and statistical research, among others--project managers select the most appropriate methodology and techniques for facilitating the research. They are responsible for producing qualitative and quantitative research plans, designing research questionnaires and moderator guides. Research project managers work with study teams, and the project and research directors, coordinate fieldwork initiatives, and conduct post-research analyses and evaluations. They use their keen eye for detail to interpret research data, author research reports, and make actionable recommendations to stakeholders.

Other Duties

Research project managers are responsible for the completion of both research and project management deliverables, including project plans and research schedules, competitive intelligence reports, progress reports and investigational applications. They broker collaborative partnerships across various research constituencies, including project heads, research directors, study teams, investigators and external collaborators. At times, research projects managers facilitate or present at research seminars, study groups and conferences.

Qualifications

A bachelor's degree is generally required to qualify for a research project management position. Many employers prefer candidates with advanced academic degrees, such as Masters in Business Administration (MBA), Masters of Science, or Doctor of Philosophy (Ph.D.). In addition, five to seven years of direct research experience is required, as well as demonstrated proficiency in project management, including budgeting, planning, execution, delivery, quality assurance, and reporting.

Qualified candidates are proactive problem solvers with superb planning, coordination, and leadership skills. They are able to communicate with stakeholders from diverse functional areas, and can convey complex data in tangible business terms.

Compensation

The median expected salary for a typical research project manager in the United States is $82,000, as of 2010. According to national income trends from Indeed.com, the average salaries for research project managers are 27 percent higher than average salaries for all job postings nationwide, as of 2010. Factors such as company size, industry, credentials and years of experience, can dramatically affect a research project manager’s salary. Meanwhile, the average salary of jobs with related titles, including research data collector, clinical data manager and executive clinical research director ranges from $26,000 to $132,000.

Related Articles

Research manager job description →.

Clinical Research Manager Job Description →

What Are the Duties of an Administrative Research Assistant? →

Project specialist job description →.

Job Description of a Research Consultant →

Junior Project Manager Job Description →

• Indeed.com: Research Project Manager Salaries
• Indeed.com: Research Director Salaries

Alyssa Guzman has written online content for eHow and Answerbag since 2010. She is a "journalist of all trades" and writes on many subjects including travel and leisure, animal health, informaton technology, business etiquette and exotic flowering plants. Guzman was a communications studies major at the Florida State University.

Kerkez/iStock/GettyImages

• Job Descriptions
• Law Enforcement Job Descriptions
• Administrative Job Descriptions
• Healthcare Job Descriptions
• Sales Job Descriptions
• Fashion Job Descriptions
• Education Job Descriptions
• Salary Insights
• Journalism Salaries
• Healthcare Salaries
• Military Salaries
• Engineering Salaries
• Teaching Salaries
• Accessibility
• Privacy Notice
• Cookie Notice
• Copyright Policy
• Contact Us
• Find a Job
• Manage Preferences
• California Notice of Collection
• Terms of Use

• News & Highlights

• Publications and Documents
• Education in C/T Science
• Browse Our Courses
• C/T Research Academy
• K12 Investigator Training
• Harvard Catalyst On-Demand
• SMART IRB Reliance Request
• Biostatistics Consulting
• Regulatory Support
• Pilot Funding
• Informatics Program
• Community Engagement
• Diversity Inclusion
• Research Enrollment and Diversity
• Harvard Catalyst Profiles

Project Management Strategies for Research Team Members

Webinar series on the principles of project management

For more information:

• Understand the foundational principles of project management.
• Explore how project management principles and strategies can influence your work with colleagues and stakeholders on various projects.

Managing projects is a detailed and systematic process. Yet, the applications of this process vary across disciplines and teams. This webinar series will introduce how to troubleshoot, forecast, and problem solve using project management in various contexts while considering how these elements impact the work of teams. Each of the four independent sessions will be led by David Vincenti, PMP, a certified project management professional. This series will identify the principles of project management and how to apply templates and skills to your work and experiences in team settings. The last session will feature a panel of guest speakers who utilize successful project management strategies in their respective roles and professions. Those without official training in this area will gain skills and confidence in project management during this series.

Boundary-Crossing Skills for Research Careers

This session explores approaches to developing a broad range of competencies integral to establishing and maintaining a successful research career. The series delves into the following competencies: team science, mentorship, project management, communication, leadership, and funding research. For more information and to access other resources and webinars in the series, please visit  Boundary-Crossing Skills for Research Careers.

Meet the Presenter

Vincenti has presented to academic and professional audiences on project management, professional development, and other topics, and has been recognized for his work with career planning for early-career technical professionals. He holds degrees in materials engineering and technology management from Stevens Institute of Technology.

Meet the Panelists

Sarita Patil, MD:  Assistant Professor of Medicine, Harvard Medical School and Assistant Physician, Massachusetts General Hospital

Jane Shim, BA : Clinical Research Coordinator, Food Allergy Center, Massachusetts General Hospital

Neal Smith, MSc : Senior Computational Biologist, Center for Immunology and Inflammatory Diseases, Massachusetts General Hospital

Yamini Virkud, MD, MA, MPH : Pediatric Allergist/Immunologist and Assistant Professor, University of North Carolina at Chapel Hill

Session dates

Session 1: Defining the Work November 1, 2022 | 12:00pm ET This session introduces basic project management principles. You will learn the definition of a project, how to manage project scope, and how to draft the baseline of a project while considering how projects can be connected.

Session 2: Creating the Plan November 3, 2022 | 12:00pm ET In this session, you will learn to apply project planning terms and understand how to break a project into manageable parts, sequence tasks, and manage time while considering how these components affect your work and the work of your team members.

Session 3: Finalizing the Plan November 8, 2022 | 12:00pm ET In this session, you will explore project management principles further by calculating risks, managing a process, reviewing a project plan, and forecasting the execution and completion of a project while considering how these elements impact your work and the work of your team members.

Session 4: Panel Discussion November 10, 2022 | 12:00pm ET This culminating session features a panel discussion with four successful project management practitioners. The panelists will share their experiences in their respective roles and professions, and discuss how they engage in project management work within team settings.

Time commitment

50-minute sessions on Zoom

This series is designed for team members in the clinical and translational (c/t ) workforce who are familiar with project management but have no formal training. Attendees are welcome to attend on their own or with their team members.

We believe that the research community is strengthened by understanding how a number of factors including gender identity, sexual orientation, race and ethnicity, socioeconomic status, culture, religion, national origin, language, disability, and age shape the environment in which we live and work, affect each of our personal identities, and impacts all areas of human health.

Eligibility

There are no eligibility requirements. Prior session attendees have included: PhD, MD, postdocs, junior faculty, and medical students.

Registration is currently closed. Please check back for future opportunities.

Related Courses

Implementation Project Manager, Life Science Research Solution Platforms

Responsibilities.

• Accountable for successful life-cycle delivery of all customer projects involving existing software and customized IT solutions.
• Serve as the primary point of contact for customers throughout the implementation process, fostering strong relationships and ensuring clear communication.
• Develop detailed project plans, timelines, and resource allocations to ensure smooth execution of implementation activities and alignment with the customer’s goals and regulatory requirements.
• Identify and mitigate risks, proactively addressing any issues that may impact project delivery.
• Create and monitor metrics, KPIs and reports for tracking the success of implementation projects, on-time and within budget.  
• Track profitability of each project and create necessary labor and process efficiencies needed.
• Provide effective reports and dashboards to senior management on a regular basis.
• Collaborate with internal teams, including software development, product management, research services, and customer success, to coordinate resources and deliverables. 
• Coordinate with functional teams to develop Epics and Stories in Jira projects. 
• Conduct thorough testing and quality assurance activities to validate the functionality and performance of implemented solutions before they are provided to the customer. 
• Solicit feedback from customers and stakeholders to continuously improve our implementation processes and product offerings. 
• Responsible for developing and maintaining expertise in Vibrent products: end to end knowledge of functionality, current and upcoming features, integrations, and possible gaps. Customers must be able to rely on you as an expert.

REQUIREMENTS

• Bachelor's degree in Business, Engineering, Computer Science, Information Technology, or a related field.
• At least 5 years of customer facing Project Management experience in the implementation of software products with responsibility for project delivery, continuous process improvement and people management.  
• At least 3 years of experience working in a software product company using common Agile methods (Scrum, Kanban, etc.). 
• 2+ years of Clinical Research experience to include Study Design and Protocols and coordination with vendors of CTMS or other Clinical Trial software solutions. 
• Experience using vendor products for eConsent, eCOA, ePRO, CTMS, IRT, eTMF, RAVE, data management. 
• Thorough understanding of IT procedures and practices, functional teams, development environments, as well as its dependencies and challenges. 
• Experience using Atlassian JIRA and Confluence 
• Deep expertise in several project management tools (Excel, SmartSheet and others) 
• Demonstrated excellence in verbal and presentation communication skills to all levels of the organization and specifically during customer and stakeholder status calls.  
• Organized with attention to detail specifically to all the moving parts of the project. 
• Excellent analytical, logical thinking, and problem-solving skills and provide alternatives and solutions to risks, issues, and roadblocks to senior stakeholders.  
• Experience with developing and improving software delivery processes. 
• Experience managing project level budgets. 

PREFERRED QUALIFICATIONS

• Experience in a Trials Success or Customer Success role with a Clinical Trials software solution company is strongly preferred. 
• Project Management Institute’s (PMI) PMP certification.  
• Master's degree in related field.

Vibrent Health Home Page

• National Research Council Canada
• Jobs available now

Project Manager, Execution and Finance Monitoring

Priority may be given to the following designated employment equity groups: women, Indigenous peoples* (First Nations, Inuit and Métis), persons with disabilities and racialized persons*.

* The Employment Equity Act , which is under review, uses the terminology Aboriginal peoples and visible minorities.

Candidates are asked to self-declare when applying to this hiring process.

City:   Ottawa; Boucherville; Mississauga; Montréal; Vancouver  

Organizational Unit:   Clean Energy Innovation  

Classification:   RCO  

Tenure:   Term  

Duration: 2 years  

Language Requirements:   Bilingual   Imperative  BBB/ BBB  

Work Arrangements:

• Due to the nature of the work and operational requirements, this position is eligible for a hybrid work arrangement (combination of working onsite and telework). Employees in this position who telework will be required to travel to the identified work site at least three times per week at their own expense.

 We recognize that Indigenous candidates may have important connections to their communities. If you are an Indigenous candidate, you may be eligible for an exception to this work arrangement. To learn more, please contact the hiring team, using the contact information below.

We are looking for a Project Manager (RCO) to join our Clean Energy Innovoation Research Centre. The Project Manager would be someone who shares our core values of Integrity, Excellence, Respect and Creativity.

The Research Center in Clean Energy Innovation is mandated to accelerate Canada’s transition to a thriving net-zero carbon economy based on clean energy and decarbonized industries. With a multidisciplinary workforce spread across 5 sites across Canada, it delivers strategic R&D programs focused on stakeholder challenges and creating positive outcomes for Canada.

Reporting to the Project Management Office Manager, the Senior System and Process Standardization Project Manager provides project management support to the research centres for the development of project charters and project management plans. The project manager also implements tools to track execution and budgets of projects.

The incumbent works in multidisciplinary teams in a matrix environment, liaising with internal and external stakeholders.

He/she plan, prepares and conduct project reviews. He/she identifies gaps with the plans and make recommendations to project managers and management team to correct the situation. He/she identify and implement improvemnets to the project  management framework in order to get consistent good results.  

Applicants must demonstrate within the content of their application that they meet the following screening criteria in order to be given further consideration as candidates:

Bachelor’s degree in engineering or science is required.

Graduation in business administration or a program specializing in project management would be an asset. Formal designation as a Project Management Professional (PMP) or Certified Associate in Project Management (CAPM) from the Project Management Institute (PMI) would be considered an asset.  

For information on certificates and diplomas issued abroad, please see Degree equivalency

• Significant experience in supporting the management of projects involving multi-disciplinary teams and multi-partner resources.
• Extensive experience in the application of project management and in using project management software tools in a R&D environment.
• Significant experience in developing and managing effective working relationships between stakeholders.
• Significant experience in risk management techniques.

Reliability Status

Bilingual Imperative BBB/BBB 

Information on language requirements and self-assessment tests

Candidates will be assessed on the basis of the following criteria:

• Extensive knowledge in the application and use of project management theory, procedures and practices and the use of project management software tools.
• Knowledge of techniques for conducting and leading project management activities such as developing project charters and management plans, budgets, costing, risk management, reporting, contracting and contract negotiations.
• Ability to create detailed project plans, coordinate team activities, run team meetings, track progress and communicate with stakeholders (internal and external).
• Management services - Client focus (Level 3)
• Management services - Communication (Level 3)
• Management services - Initiative (Level 3)
• Management services - Results orientation (Level 3)
• Management services - Teamwork (Level 3)

For this position, the NRC will evaluate candidates using the following competency profile(s): Management Services

View all competency profiles

This position is classified as a Research Council Officer (RCO), a group that is unique to the NRC. The RCO group uses a person-based classification system instead of the more common duties-based classification system. Candidates are remunerated based on their expertise, skill, outcomes and impacts of their previous work experience. The salary scale for this group is vast, from $63,470 to $179,422 per annum, which permits for employees of all levels from new graduates to world renowned experts to be fairly compensated for their contributions.

In addition, the incumbent will receive the Bilingualism Bonus of $800 per year.

NRC employees enjoy a wide-range of competitive benefits including a robust pension plan, comprehensive health and dental coverage, disability and life insurance, office closure at the end of December, and additional supports to enhance your well-being throughout your career and beyond.

Anything is possible at the National Research Council (NRC). As Canada’s leading research and technology organization, our world-renowned research pushes the boundaries of science and engineering to make the impossible, possible. Every day we explore new ideas through innovative research and help companies discover possibilities that impact Canada’s future and the world.

At the NRC, you’ll also discover new possibilities. Our supportive workplace fosters a culture of creativity, welcoming fresh perspectives and innovation at all levels. We value teamwork. You’ll collaborate across multiple fields and with the brightest minds to find creative solutions. Most importantly, you’ll discover what’s possible within you as you grow, make valuable contributions and progress in your professional journey. From ground-breaking discoveries to a life-changing career, discover your possible at the NRC.

• Relocation assistance will be determined in accordance with the NRC's directives.
• A pre-qualified list may be established for similar positions for a one year period.
• Preference will be given to Canadian Citizens and Permanent Residents of Canada. Please include citizenship information in your application.
• The incumbent must adhere to safe workplace practices at all times.
• We thank all those who apply, however only those selected for further consideration will be contacted.

Please direct your questions, with the requisition number ( 22395 ) to:

E-mail: [email protected]

Telephone: 819-360-9970  

Closing Date: 01 October 2024 - 23:59 Eastern Time 

For more information on career tools and other resources, check out  Career tools and resources

*If you are currently a term or continuing employee at NRC, please apply through the SuccessFactors Careers module from your NRC computer.

• Social media
• Mobile applications
• About Canada.ca
• Terms and conditions

Senior Regulatory Submission Project Management Specialist

• Remote - United States of America / Tarrytown, New York, United States of America
• Global Development

Job Description

This individual will be responsible for supporting document management of Clinical Trial Applications (CTA) and related health authority submissions through collaborations with internal and external key stakeholders: including Chemistry Manufacturing and Controls (CMC) team members and Contract Research Organizations (CROs), as well as corporate and collaborative partners, Regulatory Liaisons, vendor management and other cross-functional team members.

In this role, a typical day might include:

Responsible for supporting the tracking of Reference Safety Information (RSI) approvals by global health authorities, and tracking for Global Pharmacovigilance (PV) Planning Team. Additional responsibilities may include other documentation management needs for U.S. and other health authority submission activities.

Responsible for tracking Clinical Trial Application (CTA) submission deliverables

Manage CTA regulatory submission/document transfers between Regeneron and CROs. This can include scheduling meetings (Microsoft Teams) and applicable follow-up communication for deliverables.

Downloading of CTA deliverables from numerous CRO web-based systems and communicating updates to key stakeholders in a timely fashion. Uploading will also include numerous tracking platforms to help obtain metrics and communicate study updates to other teams.

Collect, upload and manage Regulatory Agency communications, in all formats (e.g. emails, Phone conversations, hard copy letters, etc.) within the Veeva Vault RIM document repository.

Brief review of regulatory packages and tracking of any issues or gaps in data collection.

Collaborates with the functional area team and key stakeholders

Communicates key RSPM related information to consumers, collects feedback, and takes action

Identifies and communicates regulatory system enhancement needs or technical issues

This role might be for you if can/have:

Knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, UDI, etc).

Knowledge and practical experience in managing global Clinical Trial Applications (e.g. IMPD) preferred

Knowledge of pharmaceutical drug and device development process.

Experience in Regulatory Affairs/Operations/information preferred.

Knowledge and practical experience with RIM technologies preferred

Knowledge of scientific industry terminology

Knowledge of categorization and classifying information

Ability to manage, and/or contribute to multiple ongoing projects simultaneously

Works well in a team-environment and can provide feedback for process or project needs.

Excellent written and oral communication skills. Self-motivated with energy and drive to work both independently and in a team environment. Can think critically and can be flexible dependent on project needs. Strong organizational skills and ability to multi-task

Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.

Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills

To be considered for this opportunity, you must have minimum a Bachelors Degree with 4+ years of relevant experience.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)