Senior Manager, Clinical Data Management, Study Lead

Regeneron Pharmaceuticals; Stati Uniti; Remoto; USD 134.000 - 219.000; Tempo pieno

Descrizione del lavoro

Regeneron Pharmaceuticals is seeking a Senior Manager, Clinical Data Management to lead the data management team supporting multiple trials in a remote-capable role in the United States. You will oversee study start-up through database lock, coordinate with CROs and vendors, and ensure quality data and compliant documentation across therapeutic areas.

The role requires 8+ years in clinical data management, a strong track record leading study teams, and familiarity with 21 CFR Part 11, ICH-GCP,

Competenze

• Bachelor’s degree in mathematics, science, or a related field.
• 8+ years of clinical data management experience in biotechnology, pharmaceutical, or health-related industry.
• Proven track record of leading studies and study teams in a data processing environment.
• CCDM certification preferred.

Mansioni

• Lead data management delivery and oversee a team of data managers across multiple trials.
• Oversee data management activities from study start-up through database lock and archiving.
• Provide sponsor oversight of CRO data management work and drive issue resolution.
• Review and approve key study documentation (DM plans, CRF design, data transfer specs).
• Maintain inspection readiness and eTMF documentation for quarterly compliance reviews.
• Monitor data quality, timelines, risks, and proactively address issues.
• Manage, coach, and develop data management staff, including recruitment and performance management.
• Lead cross-functional initiatives and deliver training as a SME.

Descrizione del lavoro

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.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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