As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.
1. Accountable for the operational oversight of assigned IISs at an operating company level from start-up (post ReCAP approval) through receipt of the final deliverable and close-out activities and that IISs are conducted in accordance with all applicable regulations/guidelines and applicable company Policies, SOPs and WI’s
2. Acts as the central contact for designated project communications, correspondence and associated documentation for assigned IISs.
3. Maintains communication with the Sponsor-Investigator and staff during all phases of the IIS regarding study progress, issue identification/resolution, contractual matters including payments and collection of required documents.
4. Monitors study progress and initiates corrective and preventative actions when the trial deviates from plans, communicates study progress and issues to IIS team members in support of Medical Affairs/R&D Study Responsible Physician/Study Responsible Scientist.
5. Ensures that contracts, budgets and payment schedules are prepared in accordance with IIS contract requirements and HCC/HCBI considerations. As required, in consultation with appropriate representatives of the operating company, ensures required contract amendments are prepared.
6. Ensures that required safety information (e.g. SAEs/NSAEs, PQCs) are reported and processed according to all applicable SOPs/WIs.
7. Accountable for budget oversight for assigned IISs including forecasting. Communicates budget discrepancies or payment delays with rationale to Operating Company representatives
8. Accountable for drug management (e.g. projections, requests) for assigned IISs.
9. For IISs not progressing to agreed contract timelines and/or budget ensures an action plan is implemented and regular status updates are provided to the Clinical Program Leader, Functional Manager, IIS Regional Lead.
10. Maintains documentation of assigned IIS in TMF and performs periodic review to ensure accuracy and completeness
11. Maintain and updates applicable company systems including, but not limited to, CTMS, TMS, SharePoint, etc. Uses study tools and management reports available to analyze study progress.
12. Develops strong therapeutic knowledge to support roles and responsibilities.
13. Establishes and maintains excellent working relationships with external working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff, internal stakeholders, including Medical Affairs and R&D Therapeutic Areas.
14. Complies with relevant training requirements.
15. Contributes to process improvement initiatives and training and mentoring or other IIS team members.
16. Participates in preparing for or conducting Health Authority inspections and internal audits.
Minimum of 5 years clinical research operations experience in the pharmaceutical industry or CRO; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
Experience in managing investigator initiated studies and study types (interventional, non-interventional and/or registries) is preferred.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.