Job Description
Are you a seasoned professional looking to make a tangible impact in the medical field? Boston Health Partners is seeking a highly skilled Senior Clinical Data Manager to join our elite team in Boston, Massachusetts.
In this pivotal role, you will oversee the integrity and accuracy of clinical data throughout the drug development lifecycle. We offer a competitive salary, comprehensive benefits, and a collaborative environment that fosters innovation and growth.
About the Role
As a Senior Clinical Data Manager, you will be responsible for the planning, execution, and quality assurance of data management activities for clinical trials. You will work closely with cross-functional teams to ensure that data is captured, processed, and reported in compliance with regulatory standards.
Responsibilities
- Lead the strategy and execution of clinical data management for Phase I-III trials.
- Ensure rigorous data quality assurance and integrity standards are met across all projects.
- Manage cross-functional teams including Biostatisticians, Clinical Scientists, and IT professionals.
- Maintain strict compliance with regulatory guidelines (FDA, EMA, ICH GCP).
- Oversee the design, validation, and implementation of electronic data capture (EDC) systems.
- Conduct regular audits and resolve data discrepancies efficiently.
- Mentor junior data managers and drive best practices within the department.
Qualifications
- Master’s degree in Life Sciences, Biostatistics, or Health Informatics (or equivalent experience).
- Minimum of 5-7 years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- In-depth knowledge of GCP regulations and regulatory submissions.
- Proficiency in database tools such as Oracle Clinical, Rave, or Medidata Rave.
- Strong technical skills in SQL, SAS, or R for data querying and manipulation.
- Excellent communication and stakeholder management skills.