Clinical Trial Project Manager

Manager responsibilities include:

Trial and portfolio coordination

• Coordination, regulatory maintenance, monitoring and timeline management of several multi-center clinical trials within the Cancer Center
• Ongoing evaluation and verification of protocol procedures, regulatory and data compliance and alignment with federal and local regulations across all participating sites
• Act as central communications liaison for all clinical trial collaborators
• Work directly with entities within and outside the organization, including Investigators, funding sponsors, collaborators and vendorsto establish workflow, monitor process and identify and resolve issues
• Identify variance across participating sites' Standard Operating Procedures and developing processes to ensure compliance
• Fulfill routine and expedited reporting requirements to all funding sponsors, monitoring boards, regulatory boards or other governing agencies (e.g. FDA, IRB, DSMB, etc)
• Occasional domestic travel required (<25%)

Supervisory:

• Provide first-line supervision to a minimum of 2-4 FTEs and/or assist with specialized management projects of equivalent responsibility.
• Hiring and training of new staff and assessment of ongoing continuing education and development needs of supervisees
• Executing performance evaluation, staff development and corrective action processes for direct report research staff, as needed
• Manage staff productivity and quality of work produced by assessing work effort on individual studies.

Management Team Responsibilities:

• Assist and consult with Senior PCORP Management on global program initiatives, including networking, program expansion and process improvement
• Stay current with federal and local regulations, guidance and quality assurance trends as they pertain to the conduct of clinical research. Assist in update and development of program operations to align with guidance.

Skills Required:

• Exceptional time management skills with the capacity to prioritize among multiple tasks and change direction in response to fluctuating demands

• Excellent written and verbal communication skills
• Ability to clarify and distill complex issues to a variety of collaborators

• Able to work successfully and independently in a remote environment while demonstrating and fostering initiative and accountability
• Able to manage diverse teams with different skillsets, work styles, and professional roles

• Motivated to help team achieve results and meet deadlines
• Identifies key priorities and helps manage change and ambiguity
• Keen ability to anticipate and address potential issues proactively
• Problem-solving skills, including the ability to gather information, identify resources, and develop alternatives

• Familiarity with the Code of Federal Regulation (CFR) and Good Clinical Practice (ICH GCP)
• Knowledge of current and developing clinical research trends
• Sounds interpersonal skills

• None

• BA/BS degree required, Master's preferred

• Minimum of 3 years research experience required, 4 years preferred.
• Minimum of 1 year of management experience required
• Prior supervisory experience within the Cancer Center Protocol Office preferred

• Orient and train new staff and may supervise a minimum of 2-4 FTEs

• None

• Duties will mainly be performed in a remote setting; limited in-office presence anticipated. Applicants may work in all states with the following exceptions: WY, ND, Puerto Rico, and the U.S. Virgin Islands.
• Less than 25% domestic travel required (1-2 field visits per month maximum)
• Position focuses on central trial coordination and does not include patient contact