PRA and our employees have won numerous awards and accolades in the CRO industry. In fact, we've been awarded 2016 Top Workplaces honor by Philly.com. The Top Workplaces recognition is based solely on the results of an employee feedback survey. In addition, many of our employees have won gold, silver, and bronze medals in various categories honoring clinical research and project management.
Responsible for the conduct of clinical trials (Phase I-IV) at the regional or global level including maintaining the study budget and timelines, ensuring adequate resources as well as the development of clinical documents.
Maintains an attitude and philosophy consistent with the Company’s standards
Develops investigator feasibility questionnaire, evaluates investigator responses and makes recommendations for investigator site participation.
Assists in developing country timeline and assists on deliverables
Estimates country budget based on study parameters including local investigator meeting costs. Develops Payment Schedule template for US
Oversees budgets and contracts to ensure trial execution is within approved country budget
Contributes towards recruitment strategy and contingency plan in partnership with other functional areas. Recommends implementation of contingency plan when necessary
Manages recruitment at country/site level in order to achieve clinical research targets
Ensures timely and accurate documentation and communication of study progress and issues. Ensures that required reports are generated within organizational guidelines. Takes appropriate action to resolve issues that are within scope and elevates issues to project team when necessary
Ensures compliance with regulatory agency and protocol requirements. Prepares for QA and FDA audits in partnership with CRAs. Responds to audits as appropriate
Assists in the Planning and coordinates investigator meetings at country/regional level
Develops and coordinates Informed Consent Form translations as necessary
Provides clinical input on CRF, CRF completion guidelines and other study related documents to ensure accuracy and timeliness for initiation of trial
Partners with clinical supplies coordinator in ordering, packaging and delivery of study drug to investigator sites. Monitors and orders additional supplies or replaces expired supplies
Partners with Lead CRA or Project Manager to determine study specific monitoring schedule
Reviews trip reports and takes corrective action as appropriate. Generates contact report with sites when necessary
Updates and ensures accuracy of CTMS at country level
Upon receipt, ensures that SAE reports are disseminated according to SOP and regulatory requirements. Initiates communication for follow up information if necessary
Alerts Medical Monitor and any other appropriate team members, to serious adverse experiences, treatment failures, and other unexpected events that occur during a study Ensures TMF is kept current for trial
Monitors CRF and DCF retrieval reports to ensure timeliness of data collection and correction
Serves as primary point of contact for CRAs, vendors and/or other functional team members
Secondary contact to site regarding routine study conduct, primary contact for urgent issues
Monitors protocol deviations throughout trial conduct
Perform Quality Control review of key documents as assigned
Review data listings upon timeline requirements
Assist with close-out activities
May assist with protocol development and study plans
Bachelor’s Degree or equivalent in an appropriate field from an accredited institution
4+ years experience as a Project Manager/Trial Manager on a Global Team (Manager of local study sites; matrix reporting structure)
Must have a broad range of clinical trial experience
Overall experience with clinical trial execution activities
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities
Telecommuting is allowed.
Additional Salary Information: We are very competitive and open to negotiation
Who we are: We know that what do helps change peoples lives for the better every single day. We know that in order for clinical development to reach its full potential, our industry needs people who truly care about each and every outcome, and we know that's the reason people come to work with us. Our employees care about what we do and they care that its done better then It's done before. We kn...ow people count on us, because that is who we are. We are PRA.
PRA Health Sciences delivers innovative drug development solutions that improve patients’ lives. Our people are passionate about clinical research, working tirelessly to provide quality results for clients. We offer exceptional experience across all phases, therapeutic areas and a broad spectrum of solutions, ranging from full-service clinical development to our pioneering Embedded model.
With 11,000+ employees covering 80+ countries, we bolster an impressive global presence with keen local insights. Our project teams harness their understanding of local regulations, standards of care and cultural customs to effectively align our approaches with each study’s unique goals.
Our affiliate in China provides comprehensive clinical research services for all major territories. With 300+ staff in 15 cities and six offices in Shanghai, Beijing, Guangzhou, Wuhan and Hong Kong, our China operations offer the necessary depth of global resources and technical support to support studies of any size and scope.
At PRA, we love what do, because we are making a difference in the lives of patients and their family members worldwide. Over the years, we have contributed to the development of numerous drugs now available to countless patients. From our scientific and medical experts to therapeutically aligned project managers and monitors, we provide the commitment and expertise needed for today’s complex studies.