29 days old

Project Manager Clinical Research - CART NEUROLOGY

Massachusetts General Hospital
Boston, Massachusetts 02115
  • Job Type
    Employee
  • Job Status
    Full Time

GENERAL SUMMARY/OVERVIEW STATEMENT:

The Project Manager will serve as the operational lead for the Center for Alzheimer Research and Treatment (CART), and Alzheimer Prevention Program, at Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH), working closely with Dr. Gad Marshall, the Director of Clinical Trials.  CART is a $100+ million dollar research enterprise, internationally recognized leader in Alzheimer’s disease clinical research, with funding from the NIH, industry, and philanthropic sources. 

This role will be based at the BWH site and includes direct supervision of 8+ research assistants, medical assistants, and administrative staff, and guidance of other members, investigators, research nurses, and collaborators for specific study tasks.  The Project Manager will establish strategic goals and objectives for program development, develop and implement policies for clinical research conduct, provide expertise in federal and hospital regulations to the unit, and be the source of training, education, and knowledge on clinical trial conduct for the program.  The Project Manager will train staff and team members on new regulations, novel issues in study design, ethics, informed consent, confidentiality, sample and data quality control, and other issues that arise with respect to the conduct of good clinical practice.  The Project Manager will also oversee IRB amendments and renewals by coordinators, and will liaise with other clinical research units at MGB.  The Project Manager will also be responsible for interaction with collaborators, leading collaborative projects through the process, and assembling annual progress reports.

In addition to working on 25+ protocols, the Project Manager will also work with the Alzheimer Clinical Trails Consortium (ACTC), a $70 million grant to create infrastructure to support the development and operations of Alzheimer’s Disease trials nationally.

 

 

 

PRINCIPAL DUTIES AND RESPONSIBILITIES: 

  • Develop cohesive Program across BWH and MGH, while collaborating with department leaders, including creating staff positions, standardizing research management systems, connecting with other research sites to expand network.
  • Supervise and develop research study coordinators, research assistants, and operational staff.
  • Meet regularly with programmatic leadership to discuss strategic planning, opportunities to enhance operations, and management approaches.
  • Ensure research integrity, including data documentation and data management, by developing best practices, provide ongoing training, and monitoring for adherence.
  • Submit invoicing to sponsors, reconciling discrepancies as necessary.
  • Formulate strategies for research participant recruitment and retention, design programs and events.
  • Coordination and management of operations of CART at BWH, where multiple Alzheimer’s disease clinical trials and observational studies take place.
  • Executes the procedural, managerial, and policy decisions of the CART leadership (Director and PI’s).
  • Supervises the activities of the research assistants and administrative assistants at CART. Mentors them in the execution of clinical research.
  • Participates in the formulation of policies and procedures for CART.
  • Participates in agreement, budget negotiations working in close collaboration with the Neurology Research Financial Manager to streamline CART’s financial operations, and maintains a thorough understanding of all financial aspects of CART.
  • Participates and oversees regulatory document submission, and IRB submission for CART studies.
  • Participates in some grant writing and proposals.
  • Responsible for oversight of all supplies, equipment, and files at CART.
  • Primary contact for outside vendors.
  • Assists with subject recruitment.
  • Serves as site liaison for the Alzheimer’s Clinical Trial Consortium (ACTC), which consists of participating in monthly calls and attending 3 meeting per year to discuss the operations of our site and other sites running AD clinical trials as part of ACTC. 

WORKING CONDITIONS:

  • Office and clinic environment.

FISCAL RESPONSIBILITY:

  • Participates in budget negotiations, working in close collaboration with the Neurology Research Financial Manager, and maintains a thorough understanding of all financial aspects of CART.

SUPERVISORY RESPONSIBILITY:

  • Has direct responsibility for management of CART staff, including the research assistants and administrative assistants.
     

Requirements

QUALIFICATIONS:

  • College degree required, Masters degree preferred.
  • At least five years of recent research experience, which includes at least two years of clinical trials coordination, required.
  • Prior supervisory experience required.
  • Project Management Professional (PMP) certification preferred, but not required.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

  • Must be able to make independent, effective decisions in appropriate situations.
  • Must have strong organizational and communication skills.
  • Excellent interpersonal skills to be able to interact with a variety of people in person and on the telephone.
  • Ability to supervise and train research staff effectively.
  • Strong database management and overall computer skills.
  • Demonstrated analytical skills and problem-solving abilities.
  • Must possess aptitude for budget management.
  • Ability to work under stress; the clinical research setting is a very busy and demanding environment.

Salary Details

Competitive salary based on years of experience

Categories

Posted: 2021-08-27 Expires: 2021-10-11

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Project Manager Clinical Research - CART NEUROLOGY

Massachusetts General Hospital
Boston, Massachusetts 02115

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