Clinical research project manager II

Clinical Research Project Manager II

The McCance Center for Brain Health in the Neurology Department at Massachusetts General Hospital (MGH) is an interdisciplinary research center with the mission to promote healthy brain aging and prevent neurodegenerative disease through innovative research. We focus on clinical trials for Alzheimer's Disease therapies including natural, drug, and lifestyle interventions. We are in an exciting phase of growth that includes launching a single site trial of a natural product combination and planning a platform trial to accelerate testing of multiple potential therapies for AD early intervention. The Clinical Research Project Manager II (PM II) will work closely with Center leadership, site teams, and collaborators across Mass General Brigham as well as externally to develop, execute, and coordinate clinical studies. The PM II will utilize a broad range of project management tools to guide internal teams and assure that all deliverables are completed on time, within scope, and are of high quality. The PM II will provide oversight and leadership throughout the project life cycle from proposal through startup, implementation, and close out and will work closely with Principal Investigators, co-investigators, site personnel, cores, and vendors on clinical trial operations. Responsible for operational management of clinical trials including planning functional infrastructure and assessing compliance with study protocol, contracts, and policies. The candidate will plan, schedule, and facilitate meetings. The candidate must demonstrate superior organizational, time management, interpersonal, and communication (written and verbal) skills, as well as intellectual independence and initiative. The PM II will contribute to the development of documents such as study protocols, informed consents, case report forms, monitoring plans, study reports, budgets, scopes of work, timelines, project plans, study progress metrics, and electronic data capture (EDC) systems and will submit documentation to the IRB, FDA, and Clinicaltrials.gov. The PM II will protect confidential and sensitive research data with integrity, ensure compliance with Good Clinical Practice (GCP), applicable FDA regulations, and Standard Operating Procedures (SOPs). The PM II will have experience in clinical trial phases of operation, including start-up, maintenance and close out phases; be detail oriented and able to manage several projects simultaneously; forge cross-functional working relationships; proactively identify issues and hurdles that may handicap the effective implementation of any given trial and resolve the issues efficiently. The ability to work both independently and as part of a team is essential to this job. This is a full-time (40 hours / week) position based out of our Assembly Row location in Somerville, MA, with occasional travel to Charlestown Navy Yard and other Mass General Brigham (MGB) sites.

Education : Bachelor's Degree Related Field of Study required.

Can this role accept experience in lieu of a degree? Yes.

Licenses and Credentials : Experience Previous related research experience 3-5 years required.

Knowledge, Skills and Abilities : Strong analytical skills and excellent judgment. Strong attention to detail and organizational skills. Knowledge of clinical research protocols. Ability to communicate effectively and professionally at all levels. Ability to work under deadlines with general guidance. Ability to identify problems and develop solutions. Strong database management and computer skills. Trains, manages, and mentors subordinate staff.