Clinical Project Manager

The Clinical Project Manager (CPM) works closely with a cross-functional team and Investigational Sites to provide coordination and oversight of scheduled clinical activities. This position will manage project timelines, communication flow and deliverables, monitor and report on projects, build site relationships, and help keep projects on track while working to address any issues that arise during the project life cycle.

Essential functions of the job include but are not limited to:

• Serve as main point of contact on projects regarding clinical operations.
• Serve as a point of contact for teams when multiple units are assigned to the same project to ensure team actions remain in synergy.
• Develop, implement, and maintain dashboards and reports.
• Assist in development of proposals, budgets, and contracts as needed.
• Support reporting for resource and financial forecasts.
• Review work product as appropriate.
• Maintain detailed daily coordination and supervision of scheduled and ongoing projects and collections.
• Prepare daily professional communications and assist in the design and implementation of new projects for both internal and external stakeholders.
• Ensure that work product complies with Precision’s SOPs, regulatory requirements and customer expectations.
• Communicate and collaborate with external investigational sites to ensure timely and accurate collections, data submission and shipping.
• Conduct site-level training.
• Communicate and collaborate within the Clinical Affairs team to maintain databases (i.e., eCRF), dashboards and other data repositories to accurately and timely reflect enrollment, status changes and inventories as needed.
• Stay apprised of all repository and laboratory operations (fresh, frozen, data entry, shipping, etc.), collaborating with department peers when communicating, coordinating and prioritizing activities as appropriate.
• Coordinate and/or conduct investigations to resolve data discrepancies and reconcile data as appropriate.
• Implement GMP/GLP/ISO/safety regulations and standards through Project Plans or other Precision documents.
• Maintain and support safe lab practices and environment.
• Maintain client relationships ensuring client timelines are met and/or exceeded.
• Manage deadlines and push the team to ensure timeliness.
• Other duties as assigned.

Qualifications:

Minimum Required:

• Bachelor’s in Biology, Information Technology or related field
• 3 years of general working experience with 2 year focused on project management or equivalent experience (i.e., clinical research assistant, CRC, or equivalent)

Other Required:

• Experience with project management software such as MS Project, Smartsheet
• Excellent communication, interpersonal, organizational and multi-tasking skills
• Team player contributing to a positive, collaborative working environment
• Proficiency with MS Word, Excel and PowerPoint
• Must be able to read, write, speak fluently and comprehend the English language
• Extended work hours may be necessary in order to meet business demands
• Reliable transportation to and from work within the required business hours

Preferred:

• 3 years of combined project or data management experience in translational sciences, translational medicine, information technology, laboratory services, clinical trial services, software development, or related field
• Industry experience preferred
• Experience with creating project plans and Gantt charts in at least one project management software tool
• Familiarization with terminology used in immunology, molecular biology or genetics
• Experience writing and executing Project Plans, CRFs, and other clinical documents
• Project management certification (PMI, PMP) or Certified Clinical Research Professional (CCRP) certification
• Candidates familiar with GLP, GMP, GCP, CLIA, and ISO regulatory guidelines