Country Study Manager
4 days left
- Experience Level
- Experienced (non-manager)
PRA and our employees have won numerous awards and accolades in the CRO industry and 2020 hasn’t been any different with gold winners in the Project Manager and Clinical Research Team of the Year at the Pharma Times awards!
We have won multiple awards across Europe, The America’s and Asia Pacific including BioPharma Asia/Phar-East Best CRO, Pharma Times Clinical Company of The Year and special recognition at the Vaccine Industry Excellent Awards.
As a Country Study 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 Country Study 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 CSM 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 CSM 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.
- 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 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.
In a world of rapid innovation, we are seeking self-starters who find passion in achieving successful outcomes by leading, directing and inspiring peers. We encourage you to bring excellent leadership skills and demonstrate ability to work and lead in a matrix team environment involving both internal and external partners.
To be successful in this position you will have:
- A solid experience working within a CRO or Pharma environment
- An excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements.
- Solid understanding of country local regulations, ICH-GCP guidelines and written standards.
- 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 Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
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