IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. They are seeking a Clinical Project Management Director who will provide operational delivery oversight for clinical trials, ensuring they are delivered on time and to plan while managing cross-functional teams and fostering a high-performing culture.
Responsibilities:
- Understand project strategy and operationalize the agreed upon approach
- Oversee the development of integrated study management plans with the core project team
- Direct the 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
- Recognize systemic issues at program or portfolio level and identify solutions with the project teams, recommend actions to improve efficiencies and oversee the implementation of best practices, address escalation items with the customer
- 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 the management and delivery of large and/or complex studies or programs of studies
- May be responsible for portfolio management with one customer or therapeutic area
- Proactively manage strategic risk (positive and negative) and contingencies 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/program/portfolio contact with customer and own relationship with key customer contact(s), communicate/collaborate with IQVIA business development as necessary
- Drive consistency of operational delivery across customer’s projects/programs/portfolio
- Build the cross-functional project/program/portfolio 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
- Responsible for ensuring the financial success of project/programs/portfolio
- Forecast and identify opportunities to accelerate activities to bring revenue forward
- Identify changes in scope and manage change control process as necessary, identify opportunities to increase scope to assist the Customer's business needs
- Identify and communicate strategic lessons learned and best practices to promote continuous improvement
- Participate in, champion and adopt function and/or corporate initiatives, changes and/or special project assignments, act as a client liaison, departmental cross-functional liaison and/or change agent
- Provide input to line managers of their project team members’ performance relative to project tasks. Recommend team members’ further professional development. Support staff development. Mentor less experienced project team members on assigned projects to support their professional development
Requirements:
- Industry experience in Biotech or BioPharma
- Proven track record in indication-level strategy and delivery within a CRO or pharmaceutical or biotech environment
- Bachelor's Degree Life sciences or related field
- Minimum 12 years of industry, clinical research experience preferred, including significant operational leadership in global trials
- Requires extensive knowledge of multiple job areas obtained through advanced education and experience
- Viewed as a leading expert within the field by peers
- Strong understanding of clinical development processes, regulatory requirements, and GCP compliance
- Experience in resource forecasting and strategic planning for complex programs