Clinical Research Program Manager Job Cambridge area,Massachusetts USA,Research/Development

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

Bachelor’s degree in a related field with 7+ years of experience or Master’s 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…