Clinical Study Manager Poland Sponsor-Dedicated Home-Based
7 days left
- Experience Level
Clinical Study Manager (Poland)
Warsaw is preferred location
Mixed - home and office based
Here at Syneos Health we are currently recruiting for a CSM to work for one the world’s leading Pharmaceutical companies.
Preferable location is Warsaw and its surroundings.
- Participates in the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time
- Supports study feasibility and country patient commitments in collaboration with Country/Cluster Trial Monitoring and Medical. Collects and manages input to the study protocol, and operational aspects of the study
- Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/EC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs for Health Authorities submissions, as required.
- Oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues, escalating as necessary
- Ensures sites are prepared for “Ready to Initiate Site” (checkpoint), inclusive of written confirmation, and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
- Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites, and internal Country/Cluster personnel
- Drives the conduct of the study, (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track
- Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for approval of enrolling above site targets. Is responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
- Maintains oversight of country level or assigned site level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues
- Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
- Conducts or coordinates local investigator meetings as needed
- Monitors the status of site budget and contract negotiations as well as the collection and review of essential documents throughout study start up under the direction of their manages
- Processes invoice able items for site level clinical study activities to allow timely payments
The ideal candidate will need the following experience / skills to be considered:
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Minimum 5 years’ experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials
- Capable of leading in a matrix environment, without direct reports
- Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution
- Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
- Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulation
- Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
- Communicates effectively in a local/global matrixed environment
- Moderate travel may be required, approximately 20%
We have a comprehensive benefits package and offer highly competitive remuneration.
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.