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About the Role
Serve as the primary Data Management (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.
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.
- 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.
Requirements
- 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.
- Collaborating with crossfunctional, geographically distributed study teams in a matrixed environment.
Skills
- Data management
- eCRF design
- Database design
- Data quality review
- Data transfer coordination
- SOP adherence
- eTMF documentation
- Risk mitigation
- Subject Matter Expert (SME)
Location
- Tarrytown, NY
Work Type
- Telecommuting permitted
- On-site
Experience Level
- 6 years of clinical data management experience
Education Level
- Bachelor’s degree in Mathematics, Pharmaceutical Science, Pharmaceutics or related field
Salary/Compensations
- $172,994.00 - $187,400.00 per year
Benefits
- 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
About the Company
- Regeneron Pharmaceuticals, Inc. is committed to building a workplace with an inclusive culture.
- Regeneron offers a competitive and comprehensive total rewards package.
Equal Opportunity
- 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.