The Clinical Project Manager provides input to the overall operational trial(s) implementation, manages trial(s) timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, and functions as the primary liaison for internal stakeholders and vendors.
Funtions:
- Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality.
- Assist in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.
- Lead the evaluation and selection of investigative sites; responsible for feasibility.
- Select, coordinate and monitor activities of vendors Review of monitoring reports and conduct co- monitoring visits, as needed.
- Develop and manage trial(s) timelines, budget and priorities.
- Participate in data review and discrepancy resolution.
- Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress.
- Generate reports to update management on conduct of trial.
- Ensure appropriate clinical trial supply plans are implemented and managed.
- Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required.
- Participate in monitoring study safety.
- Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.
- Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work.
- Assist with CRA and third party vendor training on protocols and practices.
- Lead the multi-disciplinary trials teams; include the study team meetings.
- Function as the primary contact for trial(s) between Drug Development and other departments.
- Assume responsibility to participate as a member of working groups and perform special projects, as assigned.
- Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
Qualifications:
- BS/BA degree or a relevant degree with strong emphasis on science.
- Minimum of 4 years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials.
- Minimum of 3 years leading Global trials
- Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
- Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
- Demonstrate leadership and problem solving skills.
- Experience in executing a wide range of clinical trial activities (from initiation to clinical study report).
- Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment.
- Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently.
- Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships.
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.
