This position's work location is fully remote with occasional time onsite. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).

The Clinical Trial Data Manager I 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 application of 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 sound judgment in applying data standards and best practices to novel research constructs. In doing so, the Clinical Trial Data Manager I works closely with investigators, research teams, and biostatisticians to ensure the integrity and quality of clinical trial data.

The Office of Data Quality (ODQ) provides research support to the Dana-Farber/Harvard Cancer Center with a focus on quality assurance, quality control, and process improvement. Functions of ODQ include protocol subject registration and randomization, clinical research auditing, data and safety monitoring, quality control of DF/HCC initiated clinical trial data, participation in general clinical trials education, and committee management. The Manager, Clinical Trial Data supervises all Clinical Trial Data Manager (CTDM) positions. The Manager, Clinical Trial Data reports to the Director of ODQ.

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.

The primary role of the Clinical Trial Data Manager I 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 I 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 I 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.
• Ensures coding of Adverse events meets both study and regulatory requirements.
• Generates query reports for distribution to study teams.
• For routine data requests, performs logical edit checks on the data and reviews trends in the data to identify potential errors. Manually issues queries in response.
• Collaborates with the study monitors to determine appropriate validation process for each data field. Tracks monitors’ review, source verification, and query resolution.
• Prepares and extracts data sets from the database and transfer to the study statisticians and appropriate staff to aid in analysis.
• Performs other related quality control tasks to identify discrepancies and violations. Reports findings to investigators or ODQ leadership as appropriate.

Quality Assurance:

• Monitors completeness and timeliness of clinical trial data entry.
• Generates missing data reports for distribution to research teams.
• Reviews missing data reports for significant non-compliance and notifies investigators or ODQ leadership as appropriate
• Determines when and whether data is of acceptable quality for release in response to a data request.

Customer Service:

• Acts as a resource for investigators and study teams for items related to clinical trial data
• Communicates directly with investigators and research teams regarding discrepancies and data entry processes.
• Provides superior customer service when handling research team requests and responding to questions.
• Guides research teams and investigators by encouraging best practices and assisting in the education of study team members on protocol-specific data entry requirements.
• Coordinates with research teams to prepare data for analysis and/or study completion.

Database Management:

• Verifies the accuracy and completeness of information within various systems that support clinical trial operations.
• Reviews critical data fields in the OnCore Clinical Trials Management System to ensure accuracy and consistency with institutional and departmental policies.
• Performs quality control activities on data present in various systems to identify errors or discrepancies.
• Generates reports from various systems for comparison and to aid in the conduct of quality control processes.

• Bachelor’s degree in a scientific specialty or other relevant major preferred or equivalent work experience.Â
• Â1 year of experience working in a medical or scientific research setting or comparable data-oriented role is required. ÂExperience with electronic data capture systems and electronic case report forms (InForm preferred).

ÂKNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Ability to communicate clearly and effectively with written and verbal English.
• Complex problem-solving skills.
• Ability to work independently.
• Knowledge of clinical trial regulations and procedures, data management processes and database-related technical skills.

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

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Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.

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