Clinical Data Manager
4 days ago
We are seeking a highly experienced Clinical Data Manager to lead our data management team in the United States. As a key member of our team, you will be responsible for overseeing clinical study activities from start-up through archiving, ensuring timely completion within project budget guidelines and adhering to all applicable policies and procedures.
Key Responsibilities:
- Provide high-level expertise in data management to support clinical studies.
- Supervise the implementation and execution of procedures for data quality review and data acceptance prior to data analyses and/or database lock.
- Lead data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA/WHO-DD coding.
- Support the transfer, locking, and archiving of study databases.
- Prepare recommendations for new or improved processes for data management and data flow.
- Oversee small programs with limited numbers of studies.
- Accountable for providing comprehensive program level oversight of SDMs to ensure consistency and compliance of program level standards, track milestones/deliverables, escalate and follow to resolution as necessary, and communicate program level updates to SDMs.
To be considered for this role, you must have a Bachelor's degree in Mathematics, Science, or a related field, and minimum of 10 years of clinical data management experience in biotech, pharmaceutical, or health-related industries. Certified Clinical Data Manager (CCDM) is also required. Demonstrated broad knowledge of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collections is essential.
About Us:
Lifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, and IT. We strive to provide an inclusive and diverse culture that offers comprehensive benefits to our employees, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off.
Why Work With Us?We offer a competitive salary range of $110,900.00 - $181,100.00 per year, based on location and experience. Our company values diversity, equity, and inclusion, and we are committed to creating a workplace where everyone feels valued and respected. If you're passionate about clinical data management and want to join a dynamic team, apply now to take your first step towards living the Regeneron Way.
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