Senior Manager, Clinical Data Management, Study Lead

Regeneron Pharmaceuticals, Inc.; United States; Remote; USD 134,000 - 219,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, Clinical Data Management to lead data management delivery for clinical studies in a remote-friendly model in the US.

You will supervise a data management team, collaborate with study teams, CROs and external vendors to ensure data quality and regulatory readiness. The role requires a Bachelor’s degree in a scientific field, 8+ years’ data management experience, knowledge of 21 CFR Part 11, ICH-GCP, CDISC, and demonstrated people

Qualifications

• Bachelor's degree required in mathematics, science, or related field.
• 8+ years of clinical data management experience in biotech/pharma or health-related industry.
• Proven record of leading studies and study teams in data processing environments.
• Knowledge of 21 CFR Part 11, ICH-GCP, and CDISC.
• Strong problem-solving, project management, and communication skills; ability to manage virtual teams.
• 3+ years of people management experience preferred.
• CCDM certification preferred.

Responsibilities

• Serve as the data management study lead and primary contact for study teams, CROs, and external data vendors across multiple trials.
• Oversee data management activities from study start-up through database lock and archiving.
• Provide sponsor oversight of CRO data management work, identifying gaps and driving resolution.
• Review and approve key study documentation, including data management plans, CRF design, and data transfer specifications.
• Maintain inspection readiness and eTMF documentation to meet quarterly compliance reviews.
• Monitor data quality, deliverable timelines, and risks, signaling issues proactively.
• Manage, coach, and develop data management staff, including recruitment and performance management.
• Recommend process improvements, lead cross-functional initiatives, and act as a subject matter expert delivering training.

Education

Bachelor's degree in Mathematics, Science, or a related field

Job description

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Clinical Data Management, to join our Data Management team, supporting our clinical studies across assigned therapeutic areas in a hybrid work model. In this role, you will lead data management delivery and oversee a team of data managers while collaborating with clinical study teams, CROs, and external data vendors.

When & where:

• Location: US
• Work model: Remote

Discover your role :

• Serve as the data management study lead and primary contact for study teams, CROs, and external data vendors across multiple trials
• Oversee data management activities from study start-up through database lock and archiving
• Provide sponsor oversight of CRO data management work, identifying gaps and driving them to resolution
• Review and approve key study documentation, including data management plans, CRF design, and data transfer specifications
• Maintain inspection readiness and eTMF documentation to meet quarterly compliance reviews
• Monitor data quality, deliverable timelines, and risks, calling out issues proactively
• Manage, coach, and develop data management staff, including recruitment and performance management
• Recommend process improvements, lead cross-functional initiatives, and act as a subject matter expert delivering training

This role requires:

• Bachelor's degree in mathematics, Science, or a related field
• 8+ years of clinical data management experience in biotechnology, pharmaceutical, or a health-related industry
• Proven record of leading studies and study teams in a data processing environment
• Sophisticated knowledge of applicable regulations and standards, including 21 CFR Part 11, ICH-GCP, and CDISC
• Strong problem-solving, project management, and communication skills, with the ability to motivate virtual teams in a matrix environment.
• 3+ years of people management experience preferred.
• Certified Clinical Data Manager (CCDM) certification preferred.

Does this sound like you? 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.

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.

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)
$134,400.00 - $219,200.00