Senior Clinical Project Manager

IQVIA•Durham, NC

About The Position

Senior Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Senior Project Lead is an essential member of the core project team leading the team and 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 run their own studies. The Senior Project Lead focus is on leveraging therapeutic expertise and IQVIA’s suite of solutions to drive operational excellence and strategic leadership with our customers.

Requirements

Bachelor's Degree Life sciences or related field Req
Minimum of 7 years of clinical research experience within a CRO or Pharmaceutical/Biotechnology environment, including at least 4 years of clinical trial management experience.
Experience in all aspects of clinical study planning and startup, including budget and resource planning, and execution of clinical study activities from startup through final study report.
Significant professional experience in relevant disciplines, with substantial project management experience and senior-level knowledge within the field.
Strong leadership competencies and influencing skills.
Effective verbal and written communication skills.
Demonstrated ability to foster partnerships across projects and multidisciplinary teams.
Good understanding of the drug development process, including the interfaces and interdependencies between clinical development and other functions such as nonclinical and pharmaceutical development, regulatory, and commercial/marketing.

Responsibilities

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 operationalize the agreed upon approach.
Develop integrated study management plans with the core project team.
Accountable for the strategic planning and execution of clinical studies as per the 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.
Set objectives of the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally.
Responsible for delivery and management of medium to large sized, multiple and full service, multi regional studies.
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 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)
Communicate/collaborate with IQVIA business development representatives as necessary.
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.
Forecast and identify opportunities to accelerate activities to bring revenue forward.
Identify changes in scope and manage change control process, as necessary.
Identify and communicate lessons learned and best practices to promote continuous improvement.
Adopt corporate initiatives and changes and serve as a change advocate when necessary.
Provide input to line managers of their project team members’ performance relative to project tasks.
Support staff development.
Mentor less experienced project team members on assigned projects to support their professional development.