Senior Clinical Project Manager/Clinical Project Manager

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Position Summary: The Senior/Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.

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

Serve as primary point-of-contact and primary escalation point to the client

Coordinate and oversees all functional services including external vendors to the established timeline and budget

Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. Independently drive the CO to completion and execution with support as needed.

Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope (i.e. number of sites), Sr. PM may assume all clinical activities

Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives.

Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality

Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings.

Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation

Establish tracking metrics to monitor trial and team progress towards project goals

Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise

Leads both internal and client meetings and set expectations for the project team

Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues

Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defences with proficiency

Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project

Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required

Perform other duties as assigned by management

Remain compliant with organisational training, time-reporting and any other administrative duties as required

Provides on-going feedback, for functional team members including annual performance reviews

Minimum Required:

Bachelor’s degree or equivalent combination of education/experience in science or health-related

Advanced degree preferred