Manager, Clinical Data Management Study Lead

Regeneron Pharmaceuticals; United States; Remoto; USD 115.000 - 187.000; Tempo pieno

Descrizione del lavoro

Regeneron Pharmaceuticals is seeking a Manager CDM to oversee lead data managers on assigned clinical studies and ensure data management deliverables meet Regeneron standards and timelines. You will help develop SOPs and data management plans while coordinating with external vendors and CROs.

In this role, you will provide high-level DM expertise, support eCRF/database design, and oversee data quality reviews and database lock. Remote work with travel up to 25% is expected.

Competenze

• Bachelor degree or equivalent in Mathematics, Science or related field.
• 7+ years of clinical data management experience in biotech/pharma/health.
• Experience leading data management deliverables for complex studies.
• Knowledge of SOPs, Working Practices, and Data Management Plans.

Mansioni

• Serve as the DM study lead and primary contact for study teams and CROs for one or more complex studies.
• Provide high level expertise in data management to support clinical studies.
• Advise on eCRF and database design, data quality, and reporting of database quality status.
• Oversee data quality reviews and data acceptance prior to analyses or database lock.
• Manage data transfers with CROs and third-party data sources and coding processes.
• Support transfer, locking, and archiving of study databases and scheduling across projects.
• Recommend improvements to DM processes and data flow.
• Document sponsor oversight activities from protocol review through study close-out.

Conoscenze

Data management leadership

CRO liaison

eCRF design

Database management

Formazione

Bachelor degree or equivalent in Mathematics, Science or related field

Descrizione del lavoro

Build our future together:

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.

When & where:

• Work Location:Remote
• 25% Travel may berequired

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
• 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 reportforms,clinical trial database and electronic edit checks are performed according to SOPs andWIs.
• Identifydata quality, CRO performance, documentation, process execution gapsand isaccountable for resolution.
• Document DM sponsor oversight activities from protocol review through study close-out.
• Escalate andfollow toresolutionas necessary.

This role requires:

• Bachelor Degreeor equivalent experience in Mathematics,Scienceor a related field with at least7or more years of clinical data management experiencein biotechnology, pharmaceutical or health relatedindustry
• Perform quality review and inspection readiness tasks to meet quarterly Inspection Readiness
• Review (IRR) compliance
• Followthrough ongaps until resolution,escalatingas necessary.
• Lead/oversee all data management deliverables for assigned studies:
• Ensure deliverable timelines are developed according to the businessneedand programobjectives.
• 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.
• Identifyrisks, 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. 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.

Salary Range (annually)

$114,800.00 - $187,400.00