Senior Clinical Research Program/Project Manager
GENERAL SUMMARY/ OVERVIEW STATEMENT:
The McCance Center for Brain Health in the Neurology Department at the Massachusetts General Hospital (MGH) is a Harvard affiliated Center in Boston well poised to the discovery of interventions that promote brain health. The Clinical Trials Program within the McCance Center is building up capacity for conducting state-of-the-art interventions ranging from novel small compounds to complex multi-domain lifestyle interventions aimed at promotion of brain health and prevention of neurological disorders (i.e., Alzheimer and Parkinson disease, vascular dementia). Current faculty and staff are interdisciplinary, including expertise in neurology, psychiatry, neuroscience, genetics, nutritional metabolism, exercise science, sleep, data sciences, clinical and observational research. We are looking for a Clinical Trials Manager to join our team in Boston.
PRINCIPAL DUTIES AND RESPONSIBILITIES
Relevant activities include, but are not limited to the following:
- Propose staffing needs and work directly with HR to post and hire for approved positions
- Review and approve staff salary allocations monthly
- Plans functional infrastructure to support multicenter clinical trials
- Work with leadership to develop budgets and scope of work documents for project management team activities on new projects and extension or expansion of existing trials/projects
- Educate and mentor appropriate project management teams to review, understand and ensure cross functional teams and vendors are aware of and accountable for all task outlined in scope of work documents for each project
- Represent Project Management team at appropriate leadership and strategic meetings
- Supervise, manage, direct and mentor a team of project managers
- Direct project management activities for team members regarding their tasks to ensure that project milestones are met.
- Oversee the training of staff, monitoring consistent process application and encouraging the sharing of best practices.
- Work closely with Quality Assurance Team to manage sponsor audits and respond to audit findings.
- Ensure compliance with GCP and SOPs.
- Identify/resolve operational, medical monitoring & safety issues to ensure achievement of study milestones, data quality and data integrity.
- Assist in the development and implementation of internal policies & procedures that aim to optimize the management of clinical trials.
- Oversee the writing and review of clinical documents such as protocols, informed consents, case report forms, monitoring plans, study reports and annual reports
- Oversee management of vendor performance and quality metrics through contracts and periodic review meetings adjusting scope of services as needed
- Maintain up-to-date knowledge and understanding of regulatory requirements and concerns that affect McCance Center and communicate changes to relevant personnel.
- Develop and maintain professional relationships with academic and community-based physicians, clinicians and investigators to assure alignment and good clinical input into clinical trial operations.
- Evaluates operational compliance with study protocol, contractual obligations and relevant institutional policies
- Establishes standards, guidelines and strategies for clinical operations managed by McCance Center Clinical Trials Program and Management team
- Troubleshoot study/portfolio related issues, make recommendations for resolution, and escalate as appropriate
- Take on additional tasks and responsibilities, as requested.
SKILLS & COMPETENCIES REQUIRED:
- Experience in clinical trial phases of operation, including start-up, maintenance and close out phases.
- Detail oriented and ability to multi-task and manage several projects simultaneously.
- Ability to forge cross-functional working relationships with internal and external team members/partners.
- Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of any given trial and resolve the issues efficiently.
- Excellent communication skills (verbal and written) and ability to effectively communicate with technical and non-technical people.
LICENSES, CERTIFICATIONS, and/or REGISTRATIONS:
Nursing license in the state of MA is an asset. Certified Clinical Research Professional preferred.
EDUCATION
Bachelor's Degree required. Master's Degree preferred.
EXPERIENCE
- Minimum of 7 years of progressively more responsible experience in a research related field
- Supervisory experience required
- Financial management background required
SUPERVISORY RESPONSIBILITY:
Direct: Manage of 2-5 Clinical Trial Project Managers/Coordinators
Indirect: Support direct reports, who are in direct contact with study participants
Non-Employees: Supervise outside vendors, and clinical trial sites as required per project
FISCAL RESPONSIBILITY:
Work with McCance Center leadership to develop budgets for clinical trial operations, including personnel, materials and supplies, recruitment and retention efforts.
WORKING CONDITIONS:
Lab, office and clinic research setting.
May require travel.