Job Description
BioMed Core Innovations is a leading biopharmaceutical company dedicated to discovering breakthrough therapies for complex diseases. We are currently seeking a highly skilled Senior Clinical Data Manager to join our dynamic data team. In this pivotal role, you will oversee the integrity, quality, and timeliness of clinical data across our global trials, ensuring compliance with regulatory standards and internal protocols.
We offer a competitive benefits package, opportunities for professional growth, and a collaborative environment where your expertise will directly impact patient lives. If you are passionate about data quality and clinical research, we want to hear from you.
Responsibilities
- Lead the end-to-end clinical data management lifecycle, from data capture to database lock, ensuring strict adherence to timelines.
- Establish and enforce data governance policies and procedures to maintain high standards of data integrity and accuracy.
- Collaborate with cross-functional teams, including clinical operations, biostatistics, and medical writing, to resolve data queries and discrepancies efficiently.
- Oversee the management of external vendors and data management systems, ensuring seamless integration and data transfer.
- Mentor junior data managers and provide technical guidance on database design and data cleaning methodologies.
- Prepare comprehensive reports for regulatory inspections and sponsor reviews, highlighting data quality metrics.
- Participate in protocol design and CRF (Case Report Form) development to optimize data collection processes.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field; Master’s degree preferred.
- Minimum of 5-7 years of experience in Clinical Data Management, preferably within the pharmaceutical or biotechnology industry.
- Strong proficiency in clinical data management systems (e.g., Rave, TrialLeap) and statistical software (e.g., SAS, R, SQL).
- Deep understanding of Good Clinical Practice (GCP) and ICH E6 guidelines.
- Proven track record of leading data management projects and managing cross-functional teams.
- Excellent analytical, problem-solving, and communication skills, with the ability to present complex data clearly.
- Project management certification (e.g., PMP) is a plus.