The Clinical Trial Data Manager III (CTDM III) reports to the Director of ODQ. The Clinical Trial Data Manager III performs analytical and regulatory work directly related to DFHCC’s policies, reporting requirements and adherence to local, state, and federal regulations. This position is responsible for independent application of advanced knowledge in the area of clinical research, quality assurance, and data sciences to advance DFHCC’s mission. This role requires comprehension of research study design, and significant judgment in applying data standards and best practices to novel research constructs. In doing so, the Clinical Trial Data Manager III works closely with investigators, research teams, and biostatisticians to ensure the integrity and quality of clinical trial data.
This position's work location is fully remote, never on campus. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
PRIMARY DUTIES & RESPONSIBILITIES:
The primary role of the Clinical Trial Data Manager III is to interpret DF/HCC policies, clinical trial protocols, clinical trial agreements, applicable regulations, GCP, and best practices in order to make decisions regarding the quality of clinical trial data and the appropriateness of data use and release. The Clinical Trial Data Manager III must independently determine whether data is sufficiently complete and accurate, and a request for data release for the defined business use is appropriate per policies, regulations, and best practices. The Clinical Trial Data Manager III has the authority to expedite or delay the release of clinical trial data accordingly.
Project Support/Management:
- Ensures clinical trial data collected throughout the conduct of a protocol are complete and accurate. Monitors the timely submission and completeness of clinical trial data entry, perform edit checks on the data, issue and resolve data queries, and perform other quality control and data cleanup tasks.
- Appropriately triages and prioritizes assigned Data Requests. Manages assigned tasks to meet deadlines.
- Using InForm EDC, reviews data captured on electronic case report forms to verify completion per protocol requirements.
- Reviews program-generated queries and responses, reissues queries as appropriate, and closes queries upon resolution.
- Ensure coding of Adverse events meets both study and regulatory requirements.
- Generates query reports for distribution to study teams.
- For all types of data requests, performs logical edit checks on the data and reviews trends in the data to identify potential errors. Manually issues queries i