Project Manager Gastroenterology

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Project Manager will work within the Department of Medicine- Division of Gastroenterology, Hepatology & Endoscopy. The primary role is to assist the principal investigator in conducting clinical and translation studies in inflammatory bowel disease and primary sclerosing cholangitis. Studies will be based within the Crohn's and Colitis Center & Resnek Family Center for PSC Research of Brigham and Women's Hospital. Working under the general direction of the Principal Investigator & Program Manager, the Project Manager is responsible for developing and executing work on several research projects. The Project Manager is responsible for all aspects of clinical research studies including screening, enrolling, and following subjects, managing administrative aspects of studies, monitoring study progress to assure data quality, adherence to study-specific protocols and timelines, data analysis, manuscript drafting, and submission of study manuscripts. The Project Manager participates in all decisions made for studies and identifies modifications of existing policies and procedures. Responsible for writing and editing materials to support the communication needs of the Principal Investigator, conducting literature searches using Pub Med as well as grant writing, editing, and proofreading journal articles, book chapters, and grant proposals. Within this role, the Project Manager will have numerous opportunities for education and career development, including attendance of seminars, work-in-progress meetings, and clinical case discussions. Opportunities to participate in oral or poster presentations and to contribute to manuscript preparation are also available.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Responsible for the coordination and implementation of clinical and translational research studies
• On a daily basis, executes the procedural, managerial, and policy decisions made for clinical/translational research studies, including patient identification and screening, patient enrollment and follow-up care
• Participates in clinical research study design and formulation of policies and procedures. Identifies modifications needed and work to implement solutions
• Oversees regulatory aspects of research studies including IRB amendments, continuing reviews, and reports
• Oversee, guide and direct clinical trials
• Serve as primary contact for assigned projects for both internal and external communications. Directly responds to inquiries regarding study protocol and policy. Ensures necessary research meetings are held
• Collects, reviews, and manages all study data via electronic medical records and other sources ensuring compliance with study protocols
• Responsible for performing statistical analyses using known techniques for analyzing epidemiologic data including survival analysis and adapts a variety of existing statistical methods to fulfill project needs
• Participates in writing and revising slides and papers, journal articles, book chapters, and grant proposals
• Collaborates with clinicians, medical residents, students, fellows, and other health care professionals to meet research needs including project management to set goals and timelines, ensuring these timelines are met, and supervising research trainees
• Builds data collection platforms as needed for recording study data
• Assists in preparing budgets and timelines for clinical studies

QUALIFICATIONS:

• BA/BS Required, MA/MS preferred.
• 5 years of experience in healthcare research, with experience in coordinating research projects.
• Proficiency in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, and use of the Internet required.
• Experience with IRB regulatory policies is preferred but not required

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

• Excellent interpersonal, service, management and negotiating skills, with the ability to interact professionally with faculty, staff and collaborators at all levels.
• Demonstrated knowledge of human resources philosophies.
• Ability to promote a collaborative working environment.
• Strong organizational and communication skills both written and oral. A demonstrated ability to proofread and edit scientific manuscripts and other correspondence.
• Ability to work independently and resolve complex issues, and accept responsibility as it relates to the daily operations of the office.
• Time-management, multitasking and the ability to function independently and effectively under the pressure of deadlines and schedules.
• Exceptional judgment and discretion in interacting with physicians and management on sensitive political and confidential issues.
• Ability to support multiple individuals with competing needs, is able to effectively prioritize work, and be a contributing team member with the willingness to assist with both routine and/or last minute projects.
• Ability to communicate effectively with a wide range of departments, medical staff and individuals at all levels both within

and outside the institution.

• Demonstrated strong computer and software skills.

SUPERVISORY RESPONSIBILITY:

• Directly supervises co-op students- 2 FTEs
• Oversees the work of other members of the research groups.
• Reports directly to Principal Investigator & Program Manager for each project.