Manager, Clinical Data Management Study Lead

The ManagerCDM,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.

Assistsin the development of SOPs, Working Practice, Data Management Plan, and other data management standards.

• Work Location:
  
  Remote
• 25% Travel may be required

• 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
• Providea high levelofexpertisein data management to support clinical studies.
• Provide clear verbal or written information and hands-on support to project team members and toCROs 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 dataanalysesand/or database lock.
• Manage data transfers with CROs and third-party data sources, SAE/AEreconciliationand MedDRA/WHO-DD coding.
• Support the transfer, locking, and archiving of study databases. Manage scheduling and timeconstrainsacross 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 andWIs.
• Identify data quality, CRO performance, documentation, process execution gapsand is accountable for resolution.
• Document DM sponsor oversight activities from protocol review through study close-out.
• Escalate andfollow toresolutionas necessary.

• Bachelor Degreeor equivalent experience in Mathematics,Scienceor a related field with at least7or 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
• Followthrough ongaps until resolution,escalating as necessary.
• Lead/oversee all data management deliverables for assigned studies:
• Ensure deliverable timelines are developed according to the businessneedand program objectives.
• Ensuresnapshot/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 inputto &monitordeliverable timelines.
• Monitor data quality and assess progress of data issue remediation on an ongoing basis.
• Identify risks, propose mitigations, proactively elevate operational or DM vendor or DM CRO issues.

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.

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.

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