The Psychiatric and Neurodevelopmental Genetics Unit (PNGU) in the MGH Center for Genomic Medicine (CGM) is seeking a Program Manager to manage and oversee clinical and translational research projects as well as administrative and research tasks for the research laboratory of Dr. Erin Dunn (http://www.thedunnlab.com)/.
Studies in the Dunn Lab are focused on: (1) the developmental effects of exposure to childhood adversity on risk for depression; (2) genomic, transcriptomic, and epigenomic predictors of susceptibility to depression; and (3) gene-environment interplay, or how genetic variation modifies the effect of life experience on depression. More recent projects in the lab are also aimed at identifying strategies to promote brain health across the lifespan. We are a hard-working, highly collegial, and supportive group seeking to identify motivated and dedicated team players who are curious, interested in interdisciplinary approaches, and passionate about finding ways to prevent mental illness.
The Program Manager will be responsible for day-to-day supervision and training of coordinators and other staff involved in the conduct of clinical trials; management of all regulatory activities associated with active and pending clinical trials, including compliance with sponsor guidelines, audits, sponsor progress reports, IRB submissions, and management of grant applications and administration of awarded funds. The ideal candidate must exhibit a high level of expertise and comfort in managing and facilitating objectives within a complex cross-functional project team that spans MGH clinics/departments and external sites. The position will also require regular airline travel (up to once monthly) to Florida.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
She/he will have 3 essential areas of responsibilities:
1) Day-to-day supervision and training of coordinators and other staff involved in the conduct of clinical trials
- Establishes clinical procedures and recruitment strategies and oversees the conduct of each clinical trial
- Manages selection of study team according to sponsor/study-specific guidelines and protocol operationalization.
- Responsible for hiring and providing and/or arranging training of coordinators, interns, students on study related tasks/skills.
- Directs and supervises staff members involved in daily tasks to ensure smooth and efficient operations. Ensures appropriate and equitable distribution of tasks among coordinators, students, and interns and monitors progress throughout study life cycle.
- Supervises research coordinators in the creation of study progress reports and IRB communications.
- Designs, writes, and updates manuals of operation for new and ongoing projects as needed.
- Develops an internal organizational structure to meet the needs of each study.
- Monitors progress of ongoing trials on a weekly basis. Develops action plans to address problem areas.
- Participates in all conference calls and all study-related meetings. Prepares agenda and minutes. Ensures all supportive documentation is available to persons participating in the call.
2) Management of all regulatory activities
- Ensures compliance with all sponsor guidelines, IRB and federal regulations on human subjects protection and GCP
- Generates study reports and deliverables, such as DSMB reports, IND and NIH progress reports, sponsor quarterly and end point reports
- Responsible for quality control and data audits for assurance of all research data
- Maintains and oversees all IRB-related activities
- Manages licensing/certifications as needed
3) Management of grant applications and awards
- Creates grant budgets within the MGH budget template, works with grants administrator to prepare all supporting documents for grant application; responsible for smooth and timely application process
- Interacts and coordinates with departmental and institutional research management staff regarding applicable progress reports, and tracking of awarded funds
SKILLS & COMPETENCIES REQUIRED:
- Strong Microsoft Office Software and database skills
- Ability to prepare/monitor budgets
- Ability to write research grants
- Must be familiar with the unique nature of a professional, research and academic environment
- Ability to handle sensitive and confidential information
- Working knowledge of NIH and other federal, state and foundation regulations and requirements
- Excellent communication and writing skills
- Ability to problem-solve, multi-task, and meet multiple deadlines
- Displays a high degree of initiative and independent judgment
- Innovative, detail-oriented and self motivated
- Demonstrated analytical skills
- Ability to effectively supervise staff
- Ability to work independently and interact with clients and colleagues at all levels of the institution
- Ability to design, prepare, deliver and evaluate clinical programs
- Required: Bachelor’s Degree
- Preferred: Master’s Degree
- Required: minimum of 5 years progressively more responsible research experience
- Preferred: Experience in clinical research area, preferably mental health; prior supervisory experience strongly preferred