Note: The job is a remote job and is open to candidates in USA. Regeneron Pharmaceuticals, Inc is a leading biotechnology company, and they are seeking a Manager, Clinical Data Manager Study Lead. The role involves overseeing data management activities for clinical studies, ensuring adherence to standards and timelines, and serving as the primary contact for clinical study teams and external partners.
Responsibilities
- Provide 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
- Assist in the development of SOPs, Working Practice, Data Management Plan, and other data management standards
- 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
- 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
- Escalate and follow to resolution as necessary
- 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
- 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
Skills
- 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
Benefits
- 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
- Family support benefits
Company Overview
Company H1B Sponsorship