New · posted Nov 1
Regeneron · Biotechnology
Manager, Clinical Data Manager Study Lead
- Remote, US
- Remote
- Full-time
- Manager
The role
Build our future together
The Manager Clinical Data Manager Study Lead , provides oversight of lead Data Manager(s) on assigned clinical data management studies in specific therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Assists in the development of SOPs, Working Practice, Data Management Plan, and other data management standards.
What you need
This role requires
- Bachelor Degree or equivalent experience in Mathematics, Science or a related field with at least 7 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry
- Perform quality review and inspection readiness tasks to meet quarterly Inspection Readiness
- Review (IRR) compliance
- Follow through on gaps until resolution, escalating as necessary.
- Lead/oversee all data management deliverables for assigned studies:
- Ensure deliverable timelines are developed according to the business need and program objectives.
- Ensure snapshot/lock plans are developed and collaborate with the CST for review and approval.
- Ensure regular status updates with metrics are provided to CST.
- Provide program level input to & monitor deliverable timelines.
- Monitor data quality and assess progress of data issue remediation on an ongoing basis.
- Identify risks, propose mitigations, proactively escalate operational or DM vendor or DM CRO issues.
- May provide limited program level support for a small program with limited number of studies
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
What you'll do
Discover your role
Serve as the DM study lead and the primary point of contact for clinical study teams and external partners, (e.g., external data vendors and CROs) for 1 or more complex studies within a given TA. Oversee all DM activities across all stages of the trial from study start-up through archiving. To include but not limited to the following:
- Provide a high level of expertise in data management to support clinical studies.
- Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status.
- Oversee the implementation and execution of procedures for data quality review and data acceptance prior to data analyses and/or database lock.
- Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA/WHO-DD coding.
- Support the transfer, locking, and archiving of study databases. Manage scheduling and time constrains across multiple projects.
- Prepare recommendations for new or improved processes for data management and data flow.
- Perform & document the oversight of CRO data management activities for assigned studies:
- Ensure the design, implementation and maintenance of electronic case report forms, clinical trial database and electronic edit checks are performed according to SOPs and WIs.
- Identify data quality, CRO performance, documentation, process execution gaps and is accountable for resolution.
- Document DM sponsor oversight activities from protocol review through study close-out.
Review and approve study documentation for assigned studies, (including, but not limited to):
- Data Management Plan or equivalent (includes: Data Review, Reconciliation and Cleaning, Coding, SAE Recon, Local Lab Handling activities for CRF and non-CRF data)
- Case Report Form and Completion Guidelines
- Validation specifications and data transfer specifications
Pay and benefits
$114,800 – $187,400 a year
Employer provided$114,800.00 - $187,400.00
Annual bonuses
Equity awards
401(k) company match
Health and wellness programs
Medical, dental, vision, life and disability insurance
Paid time off
Working conditions
When & where
- Location: Remote
- Travel percentage: 25%
Equal opportunity, accessibility and legal noticesRegeneron's statements, word for word
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 8% below the US median for Clinical Data Management roles at this level.
This roleEmployer provided
Manager roles in the US19 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $114,800 | — | $187,400 |
| All US (middle half) | $150,000 | $164,000 | $181,000 |
This role: Regeneron's own published range. Comparisons: the base pay employers published on open Clinical Data Management roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Data Management
The general path across 54 open Clinical Data Management roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs9
- Clinical trial conduct9
- Data and digital systems7
- Collaboration and leadership5
- GMP and compliance2
- Validation and qualification1
Company hiring pulse
Regeneron on Regulatory Jobs
- 163
- Open roles
- 140
- Distinct roles
- 11
- Locations
By discipline
- Clinical69 42%
- Quality67 41%
- Regulatory27 17%
By level
- Associate & Specialist53 33%
- Director49 30%
- Manager46 28%
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Manager, Clinical Data Manager Study Lead at Regeneron
Open until filled. $115K–$187K a year, employer provided.