Clinical Trial Project Manager
Massachusetts General Hospital(MGH)

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Division of Infectious Diseases at MGH is seeking an intellectually curious and highly organized individual with clinical research experience to serve as a Project Manager within the Infectious Diseases Clinical Research Unit (ID CRU). We are committed to fostering, cultivating, and preserving a culture of diversity, equity, and inclusion. This commitment applies to staff members at all levels as well as the patient populations we care for. The ID CRU is looking to hire a Project Manager who demonstrates these same values to join our team. The candidate will work with a multidisciplinary team from Massachusetts General Hospital and collaborators from many multi-centered international trials. The team's research is typically (but not exclusively) focused on novel therapeutic, observational studies, repository studies, and investigating new modes of care or interventions. The Project Manager will play a key role in research administration, including oversight of research activities, training, and staff onboarding, in addition to managing a designated portfolio of individual projects and potentially contributing to projects as a researcher, if interested.

Central to the ID CRU's mission is a desire to improve representation in clinical trials and, by extension, improve health equity. We seek similarly mission-driven team members who offer attention to detail, flexibility, and zpa sense of humor, which are also musts.

Given our desire to build longitudinal relationships with colleagues, collaborators, and study participants, we request a long-term commitment. Collaborations beyond two years are most welcome.

Example projects include:

• An observational study understanding the long-term impact of COVID-19 in adults.
• An interventional study evaluating the efficacy of a novel therapy to treat adults with pulmonary nontuberculous Mycobacterial Infection.
• Developing new longitudinal studies evaluating clinical outcomes in Lyme disease, developing new diagnostic assays for tick-borne pathogens, and building a biospecimen repository to support future research.
• A pilot study evaluating escalating-dose immunization with Typhim Vi vaccine as a strategy to amplify humoral immunity against Salmonella typhi in adults

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Facilitate the ID CRU staff recruitment effort, including interfacing with HR, conducting interviews, and participating in hiring decisions.
• Assist, support, and coach staff in attaining departmental and institutional required competencies, training, and certifications and ensure adherence to safe practice in the conduct of clinical research. This includes orienting new team members to the CRU-specific materials, e.g., resource manuals, checklists, etc.
• Coordinate administrative aspects of multiple active and pending projects employing tools like Asana. At the project outset, clarify project goals, deliverables, tasks, timeline, and research team. Throughout project duration, plan, track, and report on project tasks, responsible parties, timelines, etc.
• Coordinate coverage schedules for research nurses, clinical research coordinators, and investigators to ensure that study procedures are adequately covered and aligned with their respective projects.
• Develop unit standard operating procedures (SOPs) and maintain research files and case report forms (CRFs) to document study participant visits per current regulations.
• Oversee regulatory correspondence with internal and external agencies.
• Promote collaboration and a work environment conducive to teamwork and employee engagement.
• Promote forums for communication of information and opportunities for team discussion and problem-solving by running weekly staff meetings and other meetings as needed.
• Provide expertise and problem-solving in research-related study participant care situations.
• Aid the CRU staff in prioritizing projects and tasks.
• Forge local partnerships and engage in community outreach in underserved areas of Boston.
• Support local marketing functions that enhance relationships with new and existing community health centers.
• Contribute directly to scientific analysis, abstract submissions, and manuscript development as desired.
• Serve as a liaison between the financial management team and the research team regarding the status and timelines of projects and their associated funds.
• Participate in the development of strategies to provide for the financial solvency of the CRU.
• Represent the CRU in hospital and other forums and interact with sponsors in a leadership capacity.

Qualifications
SKILLS & COMPETENCIES REQUIRED:

Planning, Organizing, and Coordinating

• Skilled in identifying opportunities to improve the efficiency of research operations and subsequently execute improvements.
• Time management skills with the capability to prioritize among multiple requests from multiple individuals and the ability to change direction in response to a fluctuating work environment.
• Ability to delegate, prioritize, and assist others with prioritizing study tasks.

Team Management

• Ability to work successfully in a collaborative environment.

• Ability to manage diverse teams with different skill sets, work styles, and professional roles

Gets Results/Takes Initiative

• High personal work standards and a sense of urgency for results.

• Ability to anticipate the needs of the group in a fast-paced environment.

• Problem-solving ability, including the ability to analyze complex situations, identify resources, and imagine alternatives.

• Demonstrates initiative and identifies key priorities, even in ambiguous situations with limited direction.

• Ability to work effectively under pressure and within short time constraints.

• Consistently demonstrates a positive, "can-do" attitude.

Communication Skills

• Excellent written and verbal communication skills.

• Ability to represent the ID CRU with the utmost professionalism and ability to build strong relationships inside and outside the group.

• Ability to clarify and distill complex issues to a variety of stakeholders.

• Demonstrated ability to lead discussions/meetings and obtain cooperation and support from team.

• Cognizant and respectful of cultural differences in communication approach; bilingual and bicultural candidates are particularly encouraged to apply.

Analytical Skills

• Intellectual curiosity and willingness to learn.

• Rigorous academic and/or professional background, including healthcare work

• Extensive familiarity with clinical research

This description has been designed to indicate the general nature and level of work performed by an employee within this position. The actual duties, responsibilities, and qualifications may vary based on need.

EDUCATION:

Minimum Requirement: Master's degree.

EXPERIENCE:

• Previous leadership experience in a progressively responsible position with experience managing all aspects of clinical research study implementation required.

• Sound knowledge of the principles of SOPs, GCP, FDA, IRB, clinical research methodology, regulations, and compliance is required.

WORKING CONDITIONS

• Outpatient research setting
• In-person

The information contained in this document is intended to describe the general contents and requirements of work being performed by people assigned to this classification. It is not intended to be construed as an exhaustive statement of all duties, responsibilities, or skills of individuals so classified.

EEO Statement
Massachusetts General Hospital is an Equal Opportunity Employer actively committed to increasing the diversity of our faculty and staff. Women and members of underrepresented minority groups are strongly encouraged to apply.

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