Country Study Manager
- Experience Level
PRA remains at the forefront of digital health and our Mobile Health Platform allows for decentralized clinical trials which enables us to engage with patients virtually and in real time wherever they are in the world. Our digital health solutions leverage the technology at our patients fingertips – smartphones, laptops, activity trackers , tablets and more – to engage them in real time.
Be part of a company that is leading the way in shifting clinical research away from traditional models and creating the opportunity for better science.
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 (CSM) 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 input into the study concept, protocol, logistics and may co-ordinate other expert local input
- 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 to manage recruitment into clinical studies in accordance to relevant country commitments including contingency planning.
- 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. In some cases, may also be accountable for Regulatory Authority submissions and approvals.
- Arranges accurate translations of key study documentation into local language as required.
- Provides support / develops and negotiates Clinical Trial Agreements (depending on GSK local practices) with the investigational sites, ensuring legal input where required.
- Ensures necessary supplies are available at sites and manages local supply inventory.
- 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.
- Build close working relationships with key partners including local medical staff.
- 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.
- Ensures the quality and integrity of clinical studies conducted in the LOC by taking on appropriate business management monitoring activities
- May act as a point of contact for regulatory/compliance audits of assigned study(s); provides input into LOC and site assessment/audit proposals and delivers country response & follow-up to assessment/audit reports.
- Accountable to specify and review in-country study monitoring tracking tools, monitors key risk and performance indicators and other reports. Review all study databases to ensure 100% accuracy.
- Escalates resourcing issues to ensure that in-country study activities are appropriately resourced.
- Ensures robust communication with sites, e.g. timely communication of protocol amendments.
- Reviews and approves Monitoring Visit Reports (MVRs) for their study(s) within agreed timelines to obtain an understanding of current site status.
- Ensures ongoing management and reporting of study specific safety issues and safety report handling, as required (including SAE reporting).
- Ensures conduct of assigned studies in the country according to all applicable regulations, ICH/GCP and GSK written standards.
- Reviews, ensures completeness and maintains accuracy of Sponsor Study Records.
- Co-ordinates / contributes to end of study / program learning debriefs and identify areas for improvement.
- Acquires and maintains therapeutic area and product specific knowledge for the designated therapy area, study protocol training and all study related activities. Participate continuously in relevant training courses to improve personal/professional skills.
- Keep up to date with all the changes / required knowledge on ICH GCP, GSK written standards and attending appropriate training sessions.
- Requirement to interact and collaborate with GSK Country study staff
- Requirement to communicate and work effectively with medical staff/physicians/scientists who are often senior within their field, being mindful of their standing within the medical and/or research community.
- Interactions with key partners including ethics boards, pharmacies, vendors
What do you need to have?
- Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution; a licensed health-care professional, i.e., registered nurse
- 8 years of relevant experience
- Minimum 5 years of experience in clinical research, including a minimum of 2 years full service project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
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.
Solid understanding of country local regulations, ICH-GCP guidelines and company written standards.
Flexible and resilient with ability to evolve in changing and challenging environment.
Demonstrates good English language written and verbal communication skills in addition to proven negotiation skills.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.