Clinical Project Manager

JOB OVERVIEW
Job Profile Summary

Clinical Project Managers are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs (or Medical Devices) to the market faster. The Clinical Project Manager is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices.

Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. Clinical Project leads can run their own studies. The Project Lead focus is on leveraging therapeutic expertise and IQVIA’s suite of solutions to drive operational excellence and strategic leadership with our customers.

Responsibilities
Essential Functions

Prepare for and participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for multiple service, multiple country and/or multi regional studies. Understand project strategy and ope rationalise the agreed upon approach.

Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).

Develop integrated study management plans with the core project team.

Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.

Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.

Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.

Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.

Conduct regular team meetings and communicate appropriately to achieve objectives.

Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.

Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.

Serve as primary project contact with customer and own relationship with the project’s key customer contact(s).

Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.

Ensure the financial success of the project.

Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.

Forecast and identify opportunities to accelerate activities to bring revenue forward.

Identify changes in scope and manage change control process as necessary.

Identify lessons learned and implement best practices.

Serve as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.

Adopt corporate initiatives and changes and serve as a change advocate when necessary.

Provide input…