Clinical Leadership is focused on the delivery and quality of the contracted Clinical services within a project to achieve customer satisfaction. Focus is on leveraging clinical operations and therapeutic expertise along with the diverse IQVIA solutions to drive operational excellence particularly in respect to subject/patient recruitment and on-time high quality data collection. The Clinical Lead provides leadership of the clinical team, in support of the project leader, and in collaboration with the other functional teams, to achieve the delivery of the project’s overall objectives to the Sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our SOPs, policies and practices.
Participate in bid defense preparations. Attend bid defense presentations and lead the clinical delivery strategy for medium size and multiple country/region studies, in partnership with business development and senior project leader as needed.
Develop and maintain clinical project plans, including but not limited to clinical operations plan, recruitment and retention strategy plan, etc. to be incorporated into the integrated study management plan/project management plan.
Accountable for the clinical delivery (subject recruitment, site management, data integrity) per contract, ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
Partner with the project leaders to confirm objectives of the clinical team according to agreed-upon contract, strategy and approach. Effectively communicate and assess performance against these agreed objectives.
Ensure all appropriate subject/patient recruitment strategies are in place at the outset of the study to maximize subject/patient recruitment opportunities to achieve delivery according to contract, including, but not limited to, all outreach or digital offerings being explored and deployed.
Ensure all processes and tools are available to maximize clinical team’s ability to monitor and secure patient recruitment to the monitoring team from the outset of the study including, but not limited to a clear recruitment strategy plan, the subject/patient pathway materials and clearly defined contingency plans with agreed trigger points for deployment.
Monitor clinical progress against contract and prepare/present project information proactively to all stakeholders internally and externally as required.
Deliver the project/program according to the quality management plan. Guide CRA's and advise on critical specific study issues.
Serve as clinical project contact with customer where applicable and agreed with the project leader.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In depth knowledge of, and skill in applying applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Broad protocol knowledge; therapeutic knowledge
Strong understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates
Ability to understand customer needs and appropriately influence decision making
Knowledge of Project management practices and terminology.
Ability to develop and deliver training materials to achieve clinical team understanding of project and enable effective delivery thereof
Good understanding of project financials.
Ability to identify and organize clinical resources needed to accomplish tasks, set objectives and provide clear direction to others; experience planning activities in advance and taking account of possible changing circumstances; manages time effectively
Excellent communication and presentation skills, including good command of English language
Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues
YOU SHOULD HAVE:
Bachelor's degree in a health care or other scientific discipline with 7 years clinical research/monitoring experience; or equivalent combination of education, training and experience.
At least 4 years´ experience in the role
At least 3 years leading clinical research studies (Regional or Global experience)
Advance english level.
Therapeutical Area: Oncology, Internal Medicine, CNS or Gastrointestinal.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.