Project Manager

The ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and other infections; formerly AIDS Clinical Trials Group) at the Brigham and Women's Hospital's Division of Infectious Diseases is seeking a Project Manager interested in playing a central role in leading numerous clinical trials in HIV medicine and related viral infections.

Reporting to and working closely with theSite Principal Investigator (Site PI) of the trials team, the Project Manager will oversee all major trials activities, provide logistical, administrative, and managerial direction for this suite of clinical trials and HIV treatment trials team, including direct supervision of 1-3 research staff.

The Project Manager will serve as the center of this team, holding a pivotal role in the day-to-day operations in conjunction with all members, interfacing with patients and supporting the professional development of those they supervise.

**When applying, please upload a cover letter and resume.**

Job Responsibilities include, but are not limited to, the following:

Administration of Study Management

*Identify and monitor trial goals, deliverables, tasks, and timelines, including meeting recruitment goals and targets.

*Manage all participant recruitment and retention efforts for open protocols, including pre-screening activities, preparing protocol overview slides for clinical audiences, contacting outside sites to facilitate recruitment and coordinate retention, etc.

*Interact with study participants and respond to study-related participant inquiries.

*Oversee and coordinate all study visits with the participants, Principal Investigators and Center for Clinical Investigation.

*Develop new standard operating procedures (SOPs) and workflows and lead launch of new study procedures and project tools including but not limited to VeevaVault, OnCore, etc.

*Maintain research files and case report forms (CRFs) for documentation of study participant visits.

*Ensure research integrity and compliance by developing best practices, provide ongoing training, and monitoring for adherence to applicable regulations as well as communicating with institutional review boards.

*Serve as a liaison between the financial management team, regulatory team, and the research team including assuring allocation of charges study visit-related expenses to appropriate research funds and preparing annual itemized estimate of patient care costs (room charges, ancillary laboratory tests, imaging studies, etc) for use by ACTG Network Leadership in developing protocol costs.

*Manage responses to all site feasibility surveys from the ACTG and pharmaceutical sponors.

*Provide expertise and problem-solving in research-related participant care including but not limited to study monitoring, audits, participant retention, and deviation and adverse event reporting.

*Manage weekly team meetings to promote forums for communication of information and opportunities for team discussion and problem-solving.

*Attend monthly Community Advisory Board meetings as the primary site representative and select other community-engagement activities on behalf of the trials unit.

*Review results of safety laboratory tests performed on study participants and coordinate response to abnormal results for review by the study physicians.

*Prepares annual updates to the Site Data Quality Management Plan and annual site evaluation by NIH.

*Prepares for site monitoring visits and responds to concerns raised by study monitors.

Technical and Scientific Responsibilities

*Support PI(s) with manuscript, abstract, and presentation preparation for local and community stakeholders.

*Supervise and perform data quality checks and data management where needed.

*Facilitate communication and coordination of study activities between study site and stakeholders, such as but not limited to other CTU teams such as the MGH ACTG research teams and outpatient clinics, study sponsors and central reading centers to develop and implement workflows for advanced clinical testing, including current, in-development, and proposed procedures.

*Under supervision of PI, may perform independent analyses of ongoing study data and conduct literature reviews to identify new research questions and support scientific dissemination.

Managerial/Personnel Responsibilities

*Oversee all ACTG recruitment efforts (Clinical Research Coordinators, etc.) by interfacing with HR, conducting interviews, and participating in hiring decisions.

*Supervise Clinical Research Coordinators including hiring, orientation, training, performance evaluation, disciplinary action, etc. Onboard new study staff by creating training schedules, providing performance feedback, and developing role-specific competencies.

*Proactively take steps to help others move forward, whether it is planning project-specific meetings, getting people to make decisions, enlisting additional resources, etc.

*Promote collaboration and a work environment conducive to teamwork and employee engagement.

Qualifications:

• BS Required, MS preferred.
• Minimum of 5 years of progressively more responsible research work experience.
• Prior supervisory experience required.

*Experience in a progressively responsible position with experience in managing all aspects of clinical research including study implementation required.

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

Competencies:

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.

*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 skillsets, work styles, and professional roles.

Gets Results/Takes Initiative

*Motivated to help the team achieve results, including meeting enrollment targets and key deadlines.

*Identifies key priorities and helps manage change and ambiguity.

*Keen ability to anticipate and address potential issues proactively.

*Problem-solving skills, including the ability to gather information, identify resources, and imagine alternatives.

Communication Skills

*Excellent written and verbal communication skills.

*Ability to represent ACTG with the utmost professionalism and ability to build strong relationships inside and outside the group.

*Cognizant and respectful of cultural differences; 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, clinical trials, or other research activities.

*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.

Working conditions:

Duties will be carried out primarily on-site time at the BWH main campus in Boston. Occasional evening or weekend work may be required.

Supervisory Responsibility:

The Project Manager will supervise 1-3 research staff.