Overview
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 Project Lead 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.
Essential Functions
- Participate in bid defense presentations in partnership with Business Development and may lead presentations for smaller, less complex regional studies.
- Deliver and manage smaller, less complex regional studies.
- Develop integrated study management plans with the core project team.
- Accountable for execution of clinical studies (or assigned portion) 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.
- Set objectives of core project team and/or sub-team(s) according to contract, strategy and approach, effectively communicate and assess performance.
- Collaborate with other functional groups to support milestone achievement and manage study issues and obstacles.
- Monitor progress against contract and prepare and present project and/or sub-team information proactively to stakeholders internally and externally.
- 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 and implementing appropriate corrective and preventative action plans.
- Serve as primary or backup project contact with customer and own relationship with key customer contacts, as well as collaborate with IQVIA business development representatives where necessary.
- Build and lead the cross‑functional project team; responsible for managing cross‑collaboration and for overall project delivery to support milestone achievement and manage study issues and obstacles.
- Ensure 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 lessons learned and implement best practices.
- Serve as 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 to line managers of project team members' performance relative to project tasks.
- Support staff development and mentor less experienced project team members on assigned projects to support their professional development.
Qualifications
- Bachelor's Degree in Life sciences or related field.
- 5 years of prior relevant experience.
- 1 year project management experience or equivalent combination of education, training and experience.
- Advanced knowledge of job area and broad knowledge of other related job areas, typically obtained through advanced education combined with experience.
- Knowledge of clinical trials conduct and skill in applying applicable clinical research regulatory requirements (ICH GCP and relevant local laws, regulations and guidelines) towards clinical trial conduct.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.