Clinical Research Program Manager

We are seeking a highly motivated and experienced Clinical Research Program Manager to lead the clinical research operations of a multidisciplinary program investigating inflammatory diseases and autoimmune disease. The program brings together investigators clinicians and research teams at the Broad Institute of MIT and Harvard and Massachusetts General Hospital.

The successful candidate will be a key contributor to the Broad Institutes GaMBiT Initiative an exciting initiative aimed at understanding how genetic factors increase disease risk and using that insight to accelerate the translation of genetic discoveries into therapeutics. The role requires close collaboration with colleagues at Massachusetts General Hospital but we operate as a single highly collaborative team and our cross-functional workflow means you will work from and engage with colleagues at both locations.

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 and treatment.

The Clinical Research Program Manager will connect patient-oriented research at Massachusetts General Hospital with genomic immunologic microbiome metabolomic single-cell spatial and computational research conducted across the collaborative program. The program includes prospective clinical cohorts and studies involving detailed clinical phenotyping and the collection of blood tissue stool and other biospecimens for downstream molecular analysis.

This is a highly collaborative position at the interface of clinical research scientific investigation 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.

• Serve as a key liaison among investigators study staff the Institutional Review Board 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.

• Connect clinical cohorts and biospecimens with experimental and computational research conducted across the collaborative program.

• 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 institutes

How you work

• You bring exceptional organizational skills and attention to detail.

• Demonstrate analytical and problem-solving skills makes independent effective decisions and exercises sound judgment.

• Cross-functional collaborator with excellent interpersonal skills who builds productive working relationships with investigators clinicians research staff institutional offices and scientific collaborators.

Qualifications

• Bachelors degree in a related field with 7 years of experience or Masters degree in public health biology clinical research with 5 years of experience managing clinical or human subjects research in an academic setting.

• Minimum 2 years of experience training and supervising a team of clinical research staff.

• Excellent strategic planning and project/program management skills with demonstrated ability to lead complex projects from initiation through execution.

• Data management expertise including configuration and management of complex clinical research databases. Experience collating requested subsets of data for clinical researchers.

• Proven track record of multi-study program leadership across clinical scientific computational and administrative teams orchestrating simultaneous project portfolios with proactive problem-solving strict adherence to timelines and budget.

• Excellent written and verbal skills.

Preferred Experience

• Investigator initiated trials

• REDcap clinical research database

• PMP training or certification