Job Overview
Clinical Trial Manager are an integral part of clinical trial delivery working alongside clinical teams to improve patients lives by bringing new drugs to the market faster. The Clinical Trial manager is a member of the core project team responsible for the clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs) policies and practices. .
Essential Functions
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 through the projects lifecycle.
Ensure clinical quality delivery by identifying quality standards/requirements planning how compliance will be measured monitoring and overseeing management of clinical quality issues.
Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
Conduct regular team meetings and communicate appropriately to achieve objectives.
Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.
Qualifications
Bachelors Degree Bachelors Degree in health care or other scientific discipline required Req
Requires 5 years clinical research/monitoring experience or equivalent combination of education training and experience.
Requires broad protocol knowledge and therapeutic knowledge.;
Requires good understanding of Clinical Research industry
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
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.
Required Experience:
Manager
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more