Manager, Clinical Data Management (CDM), Study Lead

BioSpace; Village of Tarrytown (NY); On-site; USD 173,000 - 187,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Tarrytown, NY seeks a Manager Clinical Data Management (CDM), Study Lead to support clinical study teams and external partners on small to mid-size studies. You will coordinate data management activities from start-up to archiving and ensure data quality.

You will support eCRF and database design, maintain eTMF, review study documentation, and represent DM in study-level forums. Telecommuting is permitted, onsite expectations may apply.

Qualifications

• Requires a Bachelor's degree in Mathematics, Pharmaceutical Science, Pharmaceutics or related field and 6 years of clinical data management experience.
• Experience applying regulations (21 CFR Part 11, ICH GCP) to clinical data collection and management.
• Experience coordinating clinical studies within a regulated data processing environment.
• Collaborating with crossfunctional, geographically distributed study teams in a matrixed environment.

Responsibilities

• Coordinate all DM activities from study start-up to archiving.
• Provide expertise in data management, support eCRF and database design, and ensure data quality.
• Maintain eTMF documentation and perform quality reviews to ensure inspection readiness.
• Represent DM in study-level forums and meetings.

Skills

Clinical data management

Regulatory compliance

21 CFR Part 11

ICH GCP Guidelines

CDISC standards

eCRF design

CRO coordination

Data quality review

Data transfers

Crossfunctional collaboration

Education

Bachelor's degree in Mathematics, Pharmaceutical Science, Pharmaceutics or related field

Job description

(Tarrytown, NY)

Regeneron Pharmaceuticals, Inc. seeks a Manager Clinical Data Management (CDM), Study Lead (Tarrytown, NY) to serve as the primary DM supporting clinical study teams and external partners on small or noncomplex studies or supporting larger studies within a given therapeutic area. Coordinate all DM activities from study start-up to archiving. Provide expertise in data management, support eCRF and database design, and ensure data quality. Perform data quality review procedures, data acceptance, and coordinate data transfers with CROs. Document and support CRO data management activities, ensuring adherence to SOPs and identifying data quality issues. Review and approve study documentation, including DMP, CRF, and validation specifications. Maintain eTMF documentation and perform quality reviews to ensure inspection readiness. Responsible for data management deliverables, ensuring timelines align with business needs and objectives. Monitor data quality, assess data issue progress, and propose risk mitigations. May act as a Subject Matter Expert (SME) for specific topics and provide training. Represent DM in study-level forums and meetings. Telecommuting permitted.

SALARY RANGE: $172,994.00 - $187,400.00 per year

Job Requirements

Requires a Bachelors degree in Mathematics, Pharmaceutical Science, Pharmaceutics or related field and 6 years of clinical data management experience in biotechnology, pharmaceutical, or health-related industry. Must have experience with: Applying applicable regulations, including 21 CFR Part 11, ICH GCP Guidelines, and CDISC standards, to clinical data collection and management activities; Supporting and coordinating clinical studies and study teams within a regulated data processing environment; Applying data management processes and industry best practices across the clinical data lifecycle, including data collection, validation, and delivery; Evaluating existing data management workflows and recommending process improvements to meet study and organizational objectives; Resolving complex data related issues by analyzing requirements, identifying root causes, and implementing compliant solutions; Preparing and delivering written documentation and verbal communications for crossfunctional clinical study teams; and Collaborating with crossfunctional, geographically distributed study teams in a matrixed environment.

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.

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 onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

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.