As a Clinical Team Manager you will be dedicated to one of our global Pharmaceutical clients. As one of the world's leading and most trusted healthcare companies they place their core values and commitment to scientific innovation are at the heart of everything they do.
The Clinical Team Manager is pivotal to trial delivery and compound development for the global R&D organization, providing leadership and driving decisions related to the conduct of a clinical trial. The CTM leads and manages the operational implementation of country feasibility, planning and delivery of R&D Phase I-IV clinical studies within and across therapeutic areas. The CTM serves as the operational point-of-contact between the Central Study Team and in-country staff aligned to the study. Accountable for high quality execution/delivery of studies within country as defined by the protocol & per agreed timelines / budget; overall project management of study activities.Main Responsibilities:
- May provide local input into the study concept, protocol, logistics
- Assess appropriateness of study for local environment. Conducts country/site feasibility. Leads selection of sites within country; accountable for site performance.
- Ensures development and maintenance of country study plan and forecast, including budgets, resource estimates, milestones, timelines, quality, and risk planning.
- Selects & manages local vendors in accordance with local practices & in alignment with overall resourcing strategy for the study; accountable for vendor management including oversight, agreements, payments, communications & issue management.
- Accountable for the creation and management of study budgets (budget updates, expenditures including site payments across a study) and reporting of accrual to finance department.
- Manages the development of key study documents, plans & manuals according to local requirements (e.g., monitoring plan, local informed consent form, import/export licenses etc.); develops local recruitment and other site support materials.
- Ensures development of country / site-level study risk assessment to proactively identify areas at risk, develop a mitigation plan and communicate to management and study teams locally and globally.
- Responsible for submitting or assisting with (in accordance with local regulations and GSK LOC standard practice) the ethics committee/IRB submissions.
- Ensures in-country study oversight: coordinates local internal & external operational activities maintains clear visibility to sites' progress and issues; reviews in-country protocol deviations; metrics; manages in-country study communications; ensures appropriate issue escalation & follow through within country and above country; communicates status/issues effectively to central team; ensures monitoring plan is followed.
- Ensures appropriate training of in-country staff and investigator sites; coordinates & delivers operational aspects at local study meetings including investigator meetings, monitor meetings and local training.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
- Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements.
- Strong project management mindset and demonstrated ability to work and lead in a matrix team environment involving both internal and external partners.
- Effectively plans, communicates, coordinates and facilitates delivery of team objectives.
- Solid understanding of country local regulations, ICH-GCP guidelines and GSK written standards.
- Demonstrates good English language written and verbal communication skills in addition to proven negotiation skills.
Your health, your family, your career, your money - the things that matter to you, matter to us. The benefits of PRA just get better and better.PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.