Senior Manager, Clinical Data Management

The Senior Manager, CDM oversees lead Data Managers across clinical studies in specific therapeutic areas to ensure timely and high-quality data management deliverables. Responsibilities include developing SOPs, Working Practices, and Data Management Plans, as well as managing staff recruitment, development, and performance.

As a Senior Manager, a typical day may include:

Study Oversight:

• Serve as the primary DM contact for clinical teams, CROs, and external vendors.

• Oversee all DM activities from study start-up to database archiving.

• Ensure eCRF/database design, data quality, and reporting meet standards.

Data Quality & Transfers:

• Manage data transfers, SAE/AE reconciliation, and MedDRA/WHO-DD coding.

• Oversee data quality reviews and database locks.

Process Improvement:

• Recommend process improvements for data flow and management.

• Support program oversight for small programs or assist on larger ones.

Documentation & Compliance:

• Review and approve study documents (e.g., Data Management Plans, Validation Specs).

• Ensure eTMF documentation is inspection-ready and compliant.

Leadership & SME Role:

• Lead DM deliverables, risk mitigation, and issue resolution.

• Act as a subject matter expert (SME) on DM topics and deliver training.

• Represent DM in cross-functional and program-level forums.

To be considered for this role, you must meet the following requirements:

• Expertise in 21 CFR Part 11, ICH-GCP, and CDISC standards.

• Proven experience leading studies and DM teams.

• Strong problem-solving, project management, and communication skills.

• Ability to manage multiple tasks, prioritize effectively, and adapt in a fast-paced environment.

Preferred Skills:

• Experience mentoring junior staff.

• Familiarity with managing virtual teams in a matrix structure.

Work Environment:

This role demands a proactive leader who can drive data management excellence, foster team collaboration, and ensure regulatory compliance in clinical trials.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)