• Job Description

  Req#: 1128493
  !*!
  The Senior Project Manager (SPM) is responsible for managing all activities of the Clinical Research Unit (CRU) within the Center for Integrated Solutions for Infectious Diseases (CISID). Working closely with and under the direction of the two lead principal investigators of the clinical research unit, responsible for executing daily, the procedural, managerial and policy decisions made for various research studies focused on investigating human infectious disease, understanding host-pathogen interaction, and improving the diagnosis and treatment of patients with infection. Participates in all decisions made for studies within the clinical research unit and identifies modifications of existing policies and procedures. Will participate in grant writing and proposals.
  Responsible for the training and supervision of all clinical research, recruitment, sample processing and clerical staff, with the exception of medical issues which are handled by the Principal Investigators of the various research studies. Assists in the implementation and operation of all aspects of clinical studies; operationalizes protocols based on study objectives, sound research principles and regulatory requirements under the direction of the Principal Investigator. Manages all aspects of protocol implementation between the main clinical research unit (at BWH) and collaborators at other CISID affiliated institutions. The Senior Project Manager will interact routinely with physicians, scientists, nurses, research assistants, data managers, laboratory personnel, pharmacy personnel, and management. The Senior Project Manager will also ensure adherence to hospital/department policies.
  1. Responsible for the coordination and implementation of research design process and study protocols at Brigham and Women’s Hospital.
  2. On a daily basis, executes the procedural and policy decisions made for the study.
  3. Participates in all decisions made for the study and the formulation of policies and procedures. Identifies modifications needed and works to implement solutions.
  4. Participates in grant writing and proposals.
  5. Responsible for the oversight of all supplies, equipment, and files.
  6. Responsible for daily research unit operations and supervision of research assistants.
  7. Directly responds to inquiries regarding study protocol and policy. Serves as liaison with internal and external collaborators.
  8. Develops, organizes, and maintains study databases.
  9. Assists in writing protocol amendments, clarification memos and Clinical Investigator Brochures.
  10. Collaborates with sponsors to write protocol specific documents such as the Study Operations Manual and Analytical Plan.
  11. Ensures quality management activities are up-to-date and accurate, including data validation, quality control, and facilitation of sponsor monitoring/audit visits.
  12. Trains new research assistants, ensures compliance and provides training for all unit staff on new protocols and continuing GCP.
  13. Responsible for all BWH Institutional Review Board documentation including continuing reviews, amendments, and adverse event reporting.
  14. Creates informed consent documents from extracting information from the study protocol. Reviews prepared documents with physician and makes required changes.
  15. Runs unit weekly staff meetings and sets agenda.
  16. All other duties as assigned.
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  QUALIFICATIONS:
  • MS Required
  • Minimum of 7 years of progressively more responsible experience in a research related field. Prior supervisory experience required. Prior experience with financial management and data collection
    systems.
  SKILLS/ABILITIES/COMPETENCIES REQUIRED:
  · Strong organizational and communication skills.
  · Demonstrated analytical skills.
  · Effective problem-solving skills.
  · Demonstrated ability to supervise and train staff effectively.
  · Strong database management and computer skills.
  · Must possess aptitude for budget management.
  · Excellent judgement and ability to interpret information and protocol requirements.
  · Strong organizational skills to formulate and complete vigorous timetables and meet the complex requirements of concurrent study protocols.
  · Knowledge of NIH contract procedures and funding.
  · Must be able to make independent effective decisions in appropriate situations.
  SUPERVISORY RESPONSIBILITIES:
  Responsible for the overall supervision of study staff including hiring, firing, evaluating and disciplining. Will orient and train new staff members.
  
  BWH Boston Main Campus (BWHMAIN)
  75 Francis St
  Boston, 02115
  
  

• About the company

  Mass General Brigham is a Boston-based non-profit hospital and physicians network that includes Brigham and Women's Hospital and Massachusetts General Hospital, two of the nation's most prestigious teaching institutions.

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