Senior Clinical Research Project Manager

The Senior Project Manager will act as a critical liaison between MGH and the other participating sites in the Strategically Focused Research Network Center. The Senior Project Manager will:

Present reports defining project progress, problems, and solutions Implement new initiatives to support research mission and goals of excellence Liaise with Research Management, Partners Human Research Committee, Research Ventures and Licensing, Partners Clinical Trials Office, and other MGH and Department groups on Project initiatives or performance improvements Organize, facilitate, and implement operational meetings, training seminars, and study-specific team meetings Manage invoicing and reconciliation of payments for all clinical research studies Develop, monitor, and report on study budgets Provide fundraising and grant-writing assistance as necessary Serve as a project administrator, working on systems improvement, project development and establishment of project SOPs Coordinate and supervise efforts for studies and provide guidance to the study specific staff in protocol implementation, meeting recruitment goals, performing clinical procedures, and managing data collection Establish recruitment strategies and assure implementation and goal attainment on trials and other funded research Monitor study performance for subject accession and data acquisition in accordance with the protocols and conveys information to PI Work with marketing staff to create print and web presence/material about the studies Assess educational needs of investigators and study staff; design training projects and conduct or facilitate individual and/or group training sessions Lead performance improvement initiatives for the study staff to ensure that researchers are in the best environment to succeed Serve as primary resource for all regulatory and operational aspects of the studies, overseeing submission and maintenance of documentation Design and implement quality assurance systems to assure compliance Assist with expediting funding and study start-up at MGH and other participating centers Oversee collection and integrity of study data Oversee regulatory affairs of the study Field study staff questions on a day-to-day basis Meet regularly with study PI, research coordinators, and other members of the research team Assist with audit preparation as necessary Accept responsibilities for special projects as requested

A minimum of 5 to 7 years of clinical research experience interacting with patients and the medical system as related to the duties and responsibilities specified. Experience with IRB administration and data management is required.

Bachelor's degree required; master's degree preferred.

• Excellent interpersonal and management skills with facility to interact professionally at all levels and plan and initiate new activities.
• Ability to design, prepare, deliver, and evaluate SOPs, source documents and other documents.
• Ability to compile and manage data, analyze information, and produce reports.
• Clinical knowledge as required for patient interviews and chart reviews.
• Knowledge and experience with human subjects research and IRB requirements.
• Administrative skills to meet the regulatory compliance required by IRB reporting.
• Excellent written and verbal communication skills.
• High level time management skills requiring exceptional organizational skills and the ability to organize time and prioritize effectively. This includes the ability to ask for direction when appropriate and the flexibility to handle multiple tasks and deadline pressures.
• Experience with common PC computer software including Microsoft Word, PowerPoint, Excel, Outlook, and reference management software such as Reference Manager or EndNote.
• Facility with learning new computer applications.
• Perform literature searches using PubMed and other search engines and perform Internet searches using MS Internet Explorer and various search engines.
• Good proofreading skills.
• Ability to compile and manage data, analyze information, and produce reports.
• Assist with materials management, supply, inventory, and ordering of program materials.
• Excellent critical thinking skills and ability to work independently are essential
• Must be self-motivated, and highly resourceful
• Excellent verbal and written communication skills
• Excellent discretion and judgment with the ability to problem solve independently, and knowing when to escalate to leadership
• Flexibility and organizational skills in a fast-paced, complex environment
• Ability to navigate within a complex organization, e.g. to understand fit with organizational goals/priorities, build consensus, facilitate decision-making
• Ability to maintain the utmost confidentiality of sensitive and personal information
• Strong computer skills--Proficiency in Word, PowerPoint, Excel--are essential
• Ability to develop templates, organize technical information, and maintain functional schedules
• Ability to educate and conduct training sessions both on individual and group levels
• Knowledge of and compliance with all hospital, State, and Federal regulatory requirements, including hospital policy and procedures, Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and Health Insurance Portability and Accountability Act of 1996 (HIPAA)
• Comfort interacting and communicating effectively with high-level hospital administration, physicians, Principal Investigators, all levels of hospital staff, external funding agencies, and maintain a variety of internal and external contacts

Duties will be performed in clinical and office settings.

Will participate in the training, orientation and education of research staff/coordinators, interns, and volunteers.

With the help of a Grant Manager, the incumbent will be responsible for developing, monitoring, and providing regular updates to the PI on study budgets. The Project Manager will be responsible for the purchasing of study-related equipment and supplies as needed.