Clinical Research Project Manager

Mass General Brigham • Boston, MA

5d • $63,253 - $102,596 • Hybrid

About The Position

The Clinical Research Project Manager manages multiple clinical research studies and serves as a key liaison with sponsors, IRBs, core laboratories, site principal investigators, and study staff. The role coordinates trial initiation and patient recruitment, helps expedite project approvals and study start-up, contributes to project standard operating procedures and recruitment strategies, and oversees budgets and subcontracts with associated institutions.

For the Center for Clinical Investigation Coordinating Center (CCI-CC), the Project Manager reports to and works closely with the CCI-CC Director to develop, implement, and manage clinical trial operations for ongoing trials and research consortiums. The position aims to use personnel and resources effectively while maintaining high quality. It conducts clinical trial monitoring to support participant safety, data integrity, protocol compliance, and adherence to regulatory requirements and Good Clinical Practice (GCP) standards. Monitoring work includes supporting site initiation, conducting interim visits, resolving compliance and data-quality issues, and completing site close-out activities.

The role also oversees study-document development and management; regulatory submissions and records; investigational product procurement, labeling, distribution, and documentation; clinical data management and collaboration with biostatistics; safety oversight; site feasibility, activation, training, and trial conduct; study closure, reporting, archiving, and publication coordination; and quality assurance and process improvement. The position is hybrid, based at 221 Longwood Avenue, and is scheduled for 40 hours per week on the day shift.

Requirements

• Bachelor’s degree in a related field required; experience in lieu of a degree is not accepted.
• 5–7 years of research-related experience required.
• Ability to make independent and effective decisions.
• Strong organizational and communication skills.
• Ability to effectively supervise and train staff.
• Strong database management and computer skills.
• Demonstrated analytical and problem-solving skills.
• Strong budget management skills.

Nice To Haves

• Master’s degree in a related field preferred.
• 1–2 years of supervisory experience preferred.
• Clinical trial monitoring experience preferred.

Responsibilities

• Manage multiple clinical research studies and serve as a liaison with sponsors, IRBs, core laboratories, site principal investigators, and study staff.
• Coordinate trial initiation and patient recruitment, and expedite project approval and study start-up.
• Participate in developing and maintaining project standard operating procedures and develop advertising strategies to support recruitment.
• Oversee budget management and subcontracts with associated institutions.
• Work with the CCI-CC Director to develop, implement, and manage clinical trial operations for ongoing trials and research consortiums.
• Conduct clinical trial monitoring to support participant safety, data integrity, protocol compliance, and adherence to applicable regulations and GCP standards.
• Support site initiation, conduct interim monitoring visits, identify and resolve compliance and data-quality issues, and complete site close-out activities.
• Prepare study protocols, informed consent forms, recruitment materials, manuals of procedures, and site and staff training materials; provide and manage a study portal for study documents and trial materials.
• Develop and manage Investigator’s Brochures as applicable; prepare and submit IND applications, amendments, expedited safety reports, and annual progress and safety reports as applicable.
• Submit IRB applications and required reports; manage site regulatory documents and the Trial Master File; manage ClinicalTrials.gov postings; and notify the FDA of study closure as applicable.
• Purchase and procure investigational products and placebos; develop labels and pharmacy manuals; label and distribute products; and maintain product records and reporting.
• Develop case report forms, build and manage clinical databases, develop the Clinical Data Management Plan including randomization implementation, and prepare study conduct reports.
• Collaborate with biostatistics to build and manage randomization systems, develop the Statistical Analysis Plan, and conduct data analysis.
• Administer oversight committees such as the Data Safety Monitoring Board and develop pharmacovigilance and safety monitoring plans.
• Review safety data and report SAEs and SUSARs to the IRB and sponsor as applicable.
• Develop site initiation and monitoring plans; conduct site initiation, interim monitoring, and site close-out visits.
• Conduct site feasibility assessments, approve site activation, provide site training and initiation, and oversee participant recruitment, informed consent, and research procedures.
• Ensure appropriate recording of AEs, SAEs, and SUSARs; investigate and remediate site noncompliance.
• Oversee site closure and required reporting, coordinate return or destruction of unused investigational products, and notify the IRB of study closure.
• Prepare and submit final study reports; oversee archiving of site records, including the site Trial Master File; coordinate publication of trial findings; and collaborate with biostatistics on final data analysis.
• Oversee development, implementation, and administration of quality assurance processes.
• Develop metrics and tools to monitor, trend, and report performance measures.
• Facilitate or participate in communications with internal and external stakeholders regarding training, performance measures, and quality assurance.
• Supervise and train staff as needed.

Benefits

• Comprehensive benefits.
• Career advancement opportunities.
• Differentials, premiums, and bonuses as applicable.
• Recognition programs designed to celebrate contributions and support professional growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level