Manager, Clinical Data Management Study Lead

Regeneron Pharmaceuticals, Inc (USA); United States; Remote; USD 115,000 - 187,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Manager CDM to oversee lead Data Managers on assigned clinical studies. You will provide expert data management support, ensure data quality, and coordinate with external vendors and CROs to meet project timelines and Regeneron standards.

Responsibilities include designing eCRF/database solutions, overseeing data quality and transfers, and maintaining study databases from protocol review through close-out.

Qualifications

• 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.

Responsibilities

• 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.
• 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 constraints 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.

Skills

Data management leadership

Clinical data management

Stakeholder communication

Regulatory collaboration

Education

Bachelor degree or equivalent in Mathematics, Science or related field

Tools

MedDRA

WHO-DD

Job description

Build our future together: The Manager CDM, 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.

When & where:

Work Location: Remote 25% Travel may be required

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
• 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 constraints 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.

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 escalates operational or DM vendor or DM CRO issues.

Salary Range (annually) $114,800.00 - $187,400.00

Regeneron, the employer:

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
• family support benefits

Equal Opportunity Employment

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.

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.

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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/