Manager, Clinical Trials Registry

				Overview:

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

The Manager, Clinical Trials Registry is responsible for overseeing the management, compliance, and operational efficiency of Dana-Farber/Havard Cancer Center's clinical trials registry. Reporting to the Director, Office of Data Quality, in the department of Clinical Research Management, this role ensures all clinical trials are accurately registered, updated, and reported in compliance with federal regulations, institutional policies, and sponsor requirements. The Manager collaborates with investigators, research teams, and regulatory staff to maintain the integrity of clinical trial data and ensure timely submissions to registries such as ClinicalTrials.gov. This position plays a critical role in supporting the Institute's commitment to transparency, research excellence, and regulatory compliance.

The primary purpose of the Office of Data Quality (ODQ) is to develop, maintain, implement and continuously improve a program that supports the highest standards of data quality in clinical research.

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.

Responsibilities:

* Oversee the registration, maintenance, and reporting of clinical trials in compliance with federal regulations, including FDAAA 801, NIH policies, and other applicable guidelines.
* Assist investigators and study teams with accurate submissions to ClinicalTrials.gov and other applicable registries, including initial registrations, updates, and results reporting.
* Collaborate with investigators, study teams, and regulatory staff to resolve issues related to trial registration and reporting.
* Conduct regular audits of registry data to ensure accuracy, completeness, and compliance with applicable standards.
* Provide training and guidance to research staff on clinical trial registration requirements, submission processes, and best practices.
* Represent the Office of Data Quality in institutional and external meetings related to clinical trial reporting. 
* Generate reports and metrics on clinical trial registration compliance for leadership and regulatory oversight committees.
* Supervise staff, including hiring, training, and performance management. 
* Develop staff to achieve individual, team, departmental, and organizational goals by setting clear expectations and providing regular feedback. 
* Ensure compliance with policies, monitor work quality, and support career growth through mentoring and training. 
* Collaborate with senior management and HR to address performance issues and foster an inclusive and productive work environment. 

SUPERVISORY RESPONSIBILITIES:

* Directly supervises at least two staff. Hires, develops, and manages staff to achieve organizational goals. Sets clear expectations, delivers feedback, and monitors performance for quality, efficiency, and compliance with policies and procedures. Mentors staff, fosters career growth, and cultivates a positive and productive work environment.

Qualifications:

* Bachelor's degree required
* Minimum of 5 years of experience in clinical research, regulatory compliance, or clinical trial operations, with at least 2 years in a supervisory or management role.
* Certification in clinical research (e.g., CCRP, CCRC, or CCRA) preferred.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

* Comprehensive knowledge of clinical trial regulations, including FDAAA 801, ICMJE requirements, and NIH policies.
* Familiarity with ClinicalTrials.gov and other clinical trial registries, including their submission processes and requirements.
* Strong organizational and project management skills, with the ability to manage multiple priorities and deadlines.
* Excellent written and verbal communication skills, with the ability to convey complex regulatory requirements to diverse audiences.
* Proficiency in data management systems and tools, including Microsoft Office Suite and clinical trial management systems (CTMS).
* Strong analytical and problem-solving skills, with attention to detail and accuracy.
* Ability to work collaboratively with cross-functional teams and build effective relationships with stakeholders.
* Leadership and supervisory skills, including the ability to mentor and develop staff.

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.

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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Dana-Farber Cancer Institute