Sr Clinical Lead/ Assoc. Clinical Lead Director

The Associate Clinical Lead Director is responsible for clinical delivery of full service, large, multi-regional studies or a program of studies to meet contractual requirements in accordance with (Standard Operating Procedures) SOPs, policies and practices.

Tasks & Responsibilities:

Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).

Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.

Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project’s lifecycle.

Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.

Participate in bid defense preparations and meetings. Develop and present Clinical Operation Plans in partnership with Business Development and Project Leadership.

Essentials Requirements:

Bachelor's Degree Health care or other scientific discipline Req

Requires 10 years clinical research/monitoring experience or equivalent combination of education, training and experience.

Requires in-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

Requires good knowledge of project finances.

Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (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. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.