Clinical Trial Data Manager III - Office of Data Quality

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 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 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.
- Generates data reports for review by DF/HCC oversight committees (e.g., DSMB, DSMC).
- 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. Monitors shared mailbox and is responsible for ensuring timely responses to all inquiries.
- 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.

In fulfilling the above duties, the Clinical Trial Data Manager III will interpret DF/HCC policies, applicable regulations, GCP, and best practices in order to evaluate the quality of clinical trial data and make decisions regarding data release. The Clinical Trial Data Manager III has independent decision-making authority to determine whether data is sufficiently complete and accurate for the requested business use and may expedite or delay the release of clinical trial data accordingly.

The Clinical Trial Data Manager III will act as lead data manager for a large and complex data request that requires collaboration among multiple CTDMs. This involves coordinating communication and data review assignments with members of the team and tracking completion towards deadlines. The Clinical Trial Data Manager III will support updates to internal policies and work instructions, and training and mentorship of new team members and junior staff. The Clinical Trial Data Manager III will represent ODQ in meetings with other departments, investigators, and research teams.

KNOWLEDGE, 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.
- Ability to performing more advanced quality control processes.
- Strong understanding of data management processes and is able to resolve complex issues and questions independently.
- Able to provide input on overall data quality planning, procedures, and systems with an eye towards consistent improvement.
- Able to handle some projects independently, and work with CTDMs and/or the Manager of CTDM on larger projects.
- Ability to perform larger and more complex projects independently.
- Demonstrates significant database management expertise, a strong understanding of internal procedures and the relationship between connected systems and databases (e.g.InForm, OnCore, Epic, BOE, COE)
- Assist Manager of CTDM in allocating and prioritizing workloads for multiple projects, as needed
- Mentor and train CTDMs in query management and other CDM related activities
- Able to provide input on and assist the Manager of CTDM in drafting and revising departmental work instructions.
- Able to generate high-level reports and lead projects to completion.

MINIMUM JOB QUALIFICATIONS:

- Bachelor’s degree in a scientific specialty or other relevant major preferred, or equivalent work experience. Master’s degree (MPH, Biostatistics, Social Sciences, or other relevant fields) preferred.
- 3 years of relevant clinical research experience, including data collection, maintenance or monitoring.
- A strong understanding of regulatory requirements and best practices related to the conduct of human subject research (e.g., FDA regulations, ICH GCP) is required.
- Experience with electronic data capture systems and electronic case report forms (InForm preferred).
- Exceptional knowledge and/or experience in research methods, database design and programming are preferred.

SUPERVISORY RESPONSIBILITIES : None

PATIENT CONTACT: None

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 committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

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.

### EEO Poster
.
Pay Transparency Statement

The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.

For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).

$102,000.00 - $113,000.00