Description
Manage and support the operational elements and execution of studies and/or programs to ensure delivery, time and quality resulting in strong financial performance and customer satisfaction and in accordance with SOPs, policies and practices from pre-award to close-out.
Work with study(ies)/program(s) teams to focus on leveraging deep therapeutic expertise and IQVIA solutions to drive operational excellence and strategic leadership with our customers.
Essential Functions
- Participate in bid defense preparations and lead bid defense presentations in partnership with Business Development for large sized, multiple and full service, multiple country and/or multi regional studies.
- Develop and/or support on the preparation of integrated study management plans in collaboration with the core project team.
- Accountable for the strategic development and execution or delivery of clinical studies in line with agreed upon contracts while optimizing speed, quality and cost of delivery.
- Serve as primary project oversight and/or contact with customers and own relationship with the project’s key customer contact(s).
- Set objectives for the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance, providing feedback and leadership.
- 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.
- Coach and/or mentor junior team members around project delivery, planning, project review, risk management and problem solving.
- Achieve project quality by identifying and proactively managing quality risks and issues.
- May participate in executive committees as part of program leadership.
- Ensure the financial success of the project including optimal management and assignment of resources to achieve project goals and profitability.
Qualifications
- Bachelor's Degree Life sciences or related field
- Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.
- Requires 10 years clinical research experience including 6 years of project management experience or equivalent combination of education, training and experience.
- Knowledge of clinical trials, ICH GCP and relevant local laws, regulations and guidelines.
- Strong written and verbal communication skills including good command of English language.
- Strong problem solving skills, negotiation and customer management skills.
- Ability to work through others to deliver results to the appropriate quality and timeline metrics.