🌟 Join a Leading Biopharmaceutical Company in Revolutionizing CNS Therapies!
An esteemed biopharmaceutical company dedicated to pioneering novel therapies for central nervous system (CNS) disorders is currently seeking a dynamic and experienced professional to join their team. Headquartered in the vibrant city of New York, this organization is at the forefront of developing innovative solutions to address unmet needs in CNS disorders. This opportunity is offered on a full-time and permanent basis.
The anticipated salary range for this role is $115,000-$130,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity etc.
About the Role: Manager, Clinical Data Management
As a Manager, Clinical Data Management in this leading biopharmaceutical company, you will play a crucial role in ensuring the success of clinical programs. This position entails overseeing all data management aspects for assigned clinical program(s) with a strong commitment to compliance with ICH GCP, regulatory guidelines/standards, and applicable SOPs. Reporting to the Senior Director, Clinical Data Management, this role will be based at the company's HQ in New York City, requiring an on-site presence for at least three days per week.
Key Responsibilities and Duties:
- Provide Data Management (DM) oversight for multiple clinical development programs
- Lead Clinical Data Manager responsibilities on designated programs as needed
- Drive data-related vendor selection and oversight activities across multiple programs
- Manage Data Management costs and timelines effectively
- Represent the data management function in clinical and cross-functional team meetings
- Collaborate with various functions including Clinical Operations, Safety, Statistics, etc., to ensure achievement of major Data Management deliverables and milestones
- Author, review, and revise Standard Operating Procedures (SOPs)
- Lead the development and user acceptance testing of Case Report Forms (CRFs) and edit check specifications
- Conduct reviews of clinical trial data through EDC or data listings to ensure high data quality
- Ensure archival of all Data Management Trial Master File (TMF) documents
Requirements / Qualifications:
- Bachelor's degree required, with a preference for candidates with a scientific background (RN, MS, MD, PharmD, PhD, or similar)
- 5-7 years of data management experience in a biotech/pharmaceutical company or clinical research organization (CRO)
- Ability to work on site Monday, Tuesday & Thursday. Remote work not considered
- Thorough understanding of FDA, GCP, and ICH guidelines
- Strong knowledge of EDC and/or systems design (e.g., Merative Zelta, Veeva, Medrio, Rave, etc.)
- Advanced knowledge of Excel and good working knowledge of statistical programming processes
- Familiarity with Clinical Data Interchange Standards Consortium (CDISC) standards is preferred
If you are ready to make a significant impact and contribute to groundbreaking CNS therapies, we invite you to apply for the Manager, Clinical Data Management position at this leading biopharmaceutical company. Join them in embodying a culture of continual improvement and innovation while promoting knowledge sharing.