Clinical Lead

• 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.

• 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.
• Knowledge of Project management practices and terminology.
• Experience in Cardiology and Metabolism studies. (mandatory)
• 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.
• 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.

IQVIA