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Job Description Summary

The Clinical Project Manager is responsible for coordinating all efforts for the study within the Organization and through the oversight of a wide variety of vendors. The candidate will coordinate different functional groups within the clinical research department (clinical science, biostatistics, data management, medical writing, medical and safety) as well as vendors responsible for the execution of the studies, ensuring proper conduct and timely completion of all projects.

Job Description

Main responsibilities

• Manages clinical research project teams and vendors to deliver a high-quality clinical study
• Drives and manages proactively all aspects of the project management process from initiation, planning, execution, control and closure
• May assist in developing protocol concept sheet (study design, entry criteria and schedule of activities table). Reviews protocol and CRFs.
• Oversees project budgets and manages cost to budgets. In collaboration with identified vendors, develops enrollment projections and (if necessary) product supply needs as part of the budget.
• In collaboration with the identified vendors is responsible for creating and maintaining MS Project timelines for each project and uses these timelines to track and manage a project’s progress.
• In collaboration with the identified vendors is responsible for creating Project Plans (e.g. Responsibility Table, Communication Plans, Study Oversight Plan).
• Reviews study-related support materials created by the identified vendors or clinical research teams (e.g. study manual, monitoring plan, edit check manual, Listing Review process).
• Oversees actual study conduct and quality at all levels.
• Ensures all vendors and clinical research groups provide timely and quality deliverables. Informs all groups of deliverables and timeline, project developments and ensures completion according to timelines.
• Manages and coordinates all vendors involved in the clinical study (central lab, CROs, etc.) including managing the Request for Proposal processes and overall budget for each.
• Collaborates with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
• Monitors progress against contract and prepares/presents project and/or sub-team information proactively to stakeholders internally and externally.
• Manages risk (positive and negative) and contingencies proactively and leads problem solving and resolution efforts.
• Achieves project quality by identifying quality risks and issues, responding to issues raised by vendors, project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.

Background

• BA/BS or equivalent with at least 3 years of clinical project management experience in the CRO or bio-/pharmaceutical industry
• Previous experience in real-world and late phase studies
• Experience in decentralized clinical trials will be a plus
• Expertise with MS Project and Excel
• Demonstrated ability to manage and coordinate senior level scientific management personnel and to resolve project issues across organizations
• Excellent English
• Strong written and verbal communication skills
• Willing to work part time (0.4-0.6 FTE)

Languages

Education

Contract Type

Contingency Workforce