Clinical Research Program Manager

Site: Mass General Brigham Incorporated

Mass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and community service striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

Job Summary

The Center for Clinical Research Operations (CCRO) provides support across all Mass. Eye and Ear departments conduct clinical research and are structured to meet the education and quality standards for the conduct of clinical research. The position reports to the Associate Director of the CCRO within Research Management.

Responsible for direct oversight of Project Managers and Study Coordinators; Conducts hands-on training of Project Manager and Study Coordinator staff; assists in triaging day-to-day workload ensures complex regulatory areas are properly handled; and responsible for overseeing operational and financial activities for the designated team. Serves as a resource to Principal Investigators Grants Administration Human Research Protection and Departments across the Hospital.

The Clinical Research Program Manager is an active member of the Partners Central Research Management office and is a primary point of contact for Principal Investigators (PIs). The CCRO Program Manager is committed to identifying and adhering to best practices in clinical research while upholding the highest standards of integrity and fiduciary responsibility. The CCRO Program Manager will proactively address the demands of clinical research by providing exceptional customer service to the research community and collaborators in their pioneering efforts in science and medicine.

PRINCIPAL DUTIES AND RESPONSIBILITIES

Working with their Project Managers and Study Coordinators in supporting the Principal Investigators of assigned service affiliations on the full lifecycle of clinical research: from study design start-up implementation and close-out. Responsible for tracking the status of all scientific and feasibility reviews for their team. Supervises day-to-day activities of team members to provide guidance input and problem-solving techniques and to facilitate growth and professional development.

Reporting to the Director of the CCRO and the IRD Service for the oversight and management of all IRD clinical trials the Clinical Research Program Manager provides direct oversight of Project Managers and Study Coordinators within the Inherited Retinal Disease (IRD) Clinic with a focus on complex high-risk gene therapy trials. This role includes hands-on training of staff triaging daily workload and ensuring compliance with intricate regulatory requirements. The Program Manager is responsible for the operational and financial management of the assigned team and serves as a key resource to Principal Investigators (PIs) Grants Administration Human Research Protection and departments across the hospital.

As an active member of Mass General Brigham the Program Manager serves as a primary point of contact for PIs and is committed to identifying and implementing best practices in clinical research. The role upholds the highest standards of integrity and fiduciary responsibility while delivering exceptional service to the research community and collaborators advancing science and medicine.

Key Responsibilities
-Oversee multiple clinical research studies including high-risk gene therapy trials.
-Hire train and supervise Clinical Research Coordinators and Project Managers.
Serve as the primary liaison with sponsors IRBs core laboratories site PIs and study staff.
-Coordinate trial initiation patient recruitment and expedite study start-up and approval processes.
-Develop and maintain standard operating procedures (SOPs) for assigned projects.
-Design and implement advertising strategies to support recruitment efforts.
-Manage study budgets and subcontracts with affiliated institutions.
-Supervise daily operations of all study staff.
-Write and maintain operations manuals and case report forms.
-Participate in policy and procedure development for clinical studies.
-Coordinate multi-center trials in collaboration with NIH FDA and private foundations.
-Report study progress at investigator meetings.

• Bachelors of Arts or Science degree with mastery of the research process independent of field of study is required. Masters Degree or PhD preferred.
• Experience with gene therapy clinical trials is recommended.
• Minimum 5 years in clinical research setting with experience and knowledge of Good Clinical Practice guidelines and inherited retinal diseases is required.
• Prior supervisory experience preferred.
• Strong analytical communication (written and verbal) quantitative problem-solving and organizational skills required. Basic typing and computer skills including document preparation and Excel spreadsheet capabilities and medical terminology required.
• Industry-sponsored and Investigator Initiated clinical trials experience
• Attention to detail and working under deadline pressure are essential. Possess the ability to interpret information and protocol requirements and initiate appropriate actions.
• Strong interpersonal and leadership skills with the ability to train supervise mentor and support team members effectively
• Excellent judgment and ability to make independent effective decisions in appropriate situations
• Team building and conflict management skills. Ability to promote collaboration and communication within and beyond the team.

SKILLS/ABILITIES/COMPETENCIES

Project Supervision:

• Oversees assigned portfolio of Investigators within designated services ensuring regulatory and study coordinator support is provided
• Fosters productive and compliant operations of ongoing research projects.
• Assists Project Managers in developing reviewing and implementing Standard Operating Procedures for approved clinical research protocols.
• Ensure study assessments procedures and enrollment are executed per the study protocol and adhere to all regulatory and ethical policies.
• Assists with the training and supervision of Project Managers in their duties required for the writing of clinical study protocols and ancillary documents (e.g. ICFs CRFs recruitment materials) for review by the Human Studies Committee sponsor (when applicable) and other regulatory bodies.
• Works with Project Managers and Study Coordinators to ensure data integrity including management of any study computer databases.
• Responsible for ensuring that Study Coordinators maintain up-to-date accurate and complete Case Report Forms and other study documents on all study subjects
• May participate in Investigators Meetings with Sponsors for new and/or ongoing clinical trials.

Training and Oversight:

• Trains Project Managers and Study Coordinators and all involved personnel to promote adherence to protocols and regulatory requirements.
• Keeps abreast of regulatory changes and ensures their team is updated and trained as necessary.
• Ensures study staff and personnel have fulfilled all required MEE training and study-specific training requirements.
• Manages project milestones
• Manage and oversee multi-site trial operations including Clinical Coordination Data Coordination and monitoring oversight
• Oversee adherence of FDA trial requirements
• Responsible for personnel management and annual performance reviews in concert with the Clinical Research Manager.

Financial Responsibilities:

• Oversees study coordinator responsibilities for patient /subject charges to be debited against clinical study grants and may also assist in coordinating billing or study budgetary tasks with oversight from the Clinical Research Manager.
• Works with Financial Analyst to ensure budget development is on track for the respective teams studies and to ensure adherence to all Federal regulations and compliance
• Works with the Agreement Associate to ensure Sponsored agreements are on track and to weigh in on any study-specific details that may affect the contract terms.
• Ensures that all staff are properly tracking time spent on projects.
• Provides post-award oversight including a final monthly review of time tracked by Project Managers and Study Coordinators prior to having the projects charged or the Sponsors invoiced.

Compliance:

• Responsible for ensuring the team follows all regulations including federal guidelines (HIPAA OHRP etc.) for safety confidentiality and adherence/compliance of all study documentation.
• Ensures all staff adhere to DHHS guidelines including maintenance of required regulatory documents submitting adverse event reports annual reviews and other required reports to the IRB study sponsor and other agencies as necessary.
• Involved in ensuring the Project Managers properly oversee the interactions with Food and Drug Administration (FDA) including applications and other relevant compliance regulations.
• Maintain active database of all assigned studies within the office including incoming and closing projects.

Working Conditions

• Category I: Exposure to blood. Universal Precautions mandatory training required for backup support to Study Coordinators.
• Laptop provided
• Lifting of 10 to 20 lbs.
• This is a full-time onsite role at Mass Eye and Ear

Onsite

325 Cambridge Street

40

Regular

Day (United States of America)

Pay Range

$62004.80 - $90750.40/Annual

Grade

7

At Mass General Brigham we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive and any offer extended will take into account your skills relevant experience if applicable education certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however it does not encompass all elements contributing to your total compensation addition to competitive base pay we offer comprehensive benefits career advancement opportunities differentials premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religious creed national origin sex age gender identity disability sexual orientation military service genetic information and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact Human Resources at .

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