Clinical Research Project Manager, MGB Office of Clinical Research CCI

The MGB OCR CCI Project Manager will be responsible for developing and maintaining the infrastructure of research studies and clinical trial by supporting the design, planning, and management of the projects.

Principal Duties and Responsibilities:

Provides strong leadership as a liaison between the investigators, sites, and sponsors. This includes:

• Developing a plan for all projects and ensuring follow-up on all discussions, and requesting an update on projects.
• Meeting with the research team regularly to review trial projects, timelines and action items
• Manage regulatory, compliance and sponsor study start-up activities
• Foster a team environment
• Lead additional special project oversight as requested

Operational Management

Develop and maintain the infrastructure of studies and clinical trials by supporting the design, planning, and management activities, including the following:

Regulatory

*Submit IRB Applications and required reporting, including commercial IRB submissions and cede review applications

*Manage site regulatory documents and binders

*Manage ClinicalTrials.gov postings

Study documents

*Assist in preparation of protocol and informed consent forms

* Assist with recruitment materials

*Oversee preparation and maintenance of Manuals of Procedures

*Oversee site and staff training materials

*Manage study portal and access to study documents and trial materials

Education
Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred

Can this role accept experience in lieu of a degree?
No

Licenses and Credentials

Experience

• At least 2-3 years of senior clinical research coordinator or project management clinical research experience
• High proficiency withMicrosoft Office, particularly with Excel

Knowledge, Skills and Abilities

* Outstanding organizational skills are necessary to manage detailed information and priorities across competing timetables and responsibilities. Ability to plan for the timely and successful completion of short- and long-term objectives.

* Excellent verbal and written communication skills to communicate effectively with a large and diverse constituency, including senior hospital leaders, division faculty and support staff, representatives of other BWH offices, collaborating institution officials, granting agencies (NIH, industry and foundations) representatives, and vendors.

* Requires the ability to work independently to ensure protocol review, implementation and ancillaries processes run smoothly.

* High degree of analytic ability to manage the financial and human resources aspects of the position.

* Interpersonal relationship skills needed to collaborate with others and work with functional group managers, many hospital-wide department heads, administrators, and physicians in a positive and collegial fashion.

* Comfortable using systems to create, update, maintain and disseminate data and reports.

* Demonstrated project and program management skills; ability to prioritize initiatives and ensure timely execution and follow through

* Proven ability to balance "big picture" strategic planning with specific and detail focused deliverables

* Skilled and knowledgeable liaison between high level academics, industry, and philanthropic partners

* Demonstrated time management and organization skills

* Knowledge of current and developing pre-clinical and clinical research trends

* Sound interpersonal skills

* Works well independently and in groups; displaying initiative and diplomacy while maintaining important work relationships

* Demonstrated ability to successfully manage multiple projects