Senior Clinical Project Manager – Global Study Leadership

Role Overview

• 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 operationalise 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.

Requirements

• Bachelor's Degree Life sciences or related field
• Requires greater than 7 years clinical research experience including at least 4 years of project management experience at a CRO
• Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.
• Knowledge of clinical trials
• Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge, therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• Professional development