Clinical Research Program ManagerSenior Clinical Research Program Manager

Site: The General Hospital Corporation

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

We are seeking a highly motivated and experienced Clinical Research Program Manager/Senior Clinical Research Program Manager to lead the clinical research operations of a multidisciplinary program investigating inflammatory diseases.

Our research seeks to understand why disease develops why it progresses differently among individuals why patients respond differently to therapy and how these insights can be translated into better interventions for patients. By deeply characterizing patients and integrating clinical information with molecular and cellular measurements we aim to identify mechanisms of disease biomarkers of disease activity and treatment response and ultimately new opportunities for prevention treatment and therapeutic intervention.

The Clinical Research Program Manager will work closely with investigators at MGH and the Broad Institute of MIT and Harvard connecting patient-oriented clinical research with cutting-edge genomic immunologic microbiome metabolomic single-cell and spatial approaches. The program includes prospective clinical cohorts and studies involving detailed clinical phenotyping and collection of blood tissue stool and other biospecimens for downstream molecular analysis.

This is a highly collaborative position at the interface of clinical research translational science and research operations. The successful candidate will provide strategic and operational leadership across multiple clinical studies supervise clinical research staff and work closely with physicians scientists computational researchers and institutional research teams to ensure that complex studies are executed rigorously and efficiently.

What You Will Do

• Manage the day-to-day operations of multiple clinical research studies in inflammatory and immune-mediated conditions.
• Work closely with principal investigators and multidisciplinary scientific teams to design initiate and implement human subjects research protocols and safety monitoring plans.
• Directly supervise train and support Clinical Research Coordinators and other study staff including oversight of patient recruitment medical-record abstraction biospecimen acquisition and processing and data quality.
• Coordinate study initiation and start-up activities and help ensure that regulatory operational and scientific requirements are addressed efficiently.
• Prepare and submit human subjects research protocols amendments continuing reviews and related materials to the Institutional Review Board (IRB).
• Serve as a key liaison among investigators study staff the IRB sponsors and funding organizations core laboratories and collaborating research teams.
• Develop study operations manuals standard operating procedures Case Report Forms and other study documentation.
• Establish project plans forecast milestones track progress identify risks and dependencies and ensure that projects remain aligned with scientific and leadership goals.
• Report study progress at investigator and project meetings and prepare study-related reports for research teams funding organizations and regulatory agencies.
• Oversee clinical research databases and workflows to ensure the quality integrity and appropriate handling of clinical and research data.
• Coordinate the collection processing tracking and transfer of biospecimens used for genomic transcriptomic immunologic microbiome metabolomic single-cell spatial and other molecular analyses.
• Facilitate approved sharing of data and biospecimens with collaborators in accordance with study protocols Data Use Agreements and institutional requirements.
• Partner closely with researchers at the Broad Institute to connect clinical cohorts and biospecimens with advanced experimental and computational research.
• Participate in the development and implementation of recruitment strategies for clinical studies.
• Oversee study budgets and associated research expenditures and coordinate subcontracts or other agreements with participating institutions as needed.
• Develop and maintain policies procedures and systems that support consistent high-quality clinical research operations.
• Identify operational challenges anticipate study needs and independently develop practical solutions that allow clinical and scientific teams to work effectively.

Education Qualifications

• Bachelors degree in a related field required.
• Masters degree in public health biology clinical research or a related field preferred
• Can this role accept experience in lieu of a degree No

Experience Qualifications

• 5 years of research-related experience required.
• 2 years of supervisory experience strongly preferred
• 2 years experience managing clinical or human subjects research preferred.
• Experience with REDcap clinical research database and data management preferred.

Skills and Abilities

• Strong strategic planning and project management skills with demonstrated ability to lead complex projects from initiation through execution.
• Ability to make independent effective decisions and exercise sound judgment.
• Strong organizational skills and exceptional attention to detail.
• Excellent written and verbal communication and interpersonal skills.
• Ability to effectively supervise train and support 2 or more research staff.
• Demonstrated ability to work across clinical scientific computational and administrative teams.
• Ability to manage multiple studies and priorities simultaneously while anticipating problems and maintaining timelines.
• Strong database management and computer skills.
• Demonstrated analytical and problem-solving skills.
• Strong budget management skills.
• Ability to build productive working relationships with investigators clinicians research staff institutional offices and scientific collaborators.

Research Environment

The Clinical Research Program Manager will participate in an unusually integrated clinical and translational research environment in which carefully characterized patient cohorts provide the foundation for mechanistic studies of human disease.

Recent work involving these clinical research programs has used multi-omic profiling to identify microbial features associated with response to biologic therapy single-cell approaches to define immune dysregulation in Crohns disease and single-cell and spatial transcriptomics to identify cellular networks associated with intestinal fibrosis. While inflammatory bowel disease remains a central focus of the program related studies are extending these approaches to other inflammatory and immune-mediated diseases including allergic disease cardiovascular disease as well as selected conditions at the gutbrain interface.

These projects illustrate the broader goal of the program: to build deeply characterized clinical cohorts and connect observations in patients to biological mechanisms that can ultimately inform diagnosis patient stratification intervention and treatment

Onsite

185 Cambridge Street

40

Regular

Day (United States of America)

Pay Range

$63252.80 - $102596.00/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.

1200 The General Hospital Corporation 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 .