Docs Global (Continental Europe)

Regional Trial Manager/ office-based or home-based multiple FTEs

Warsaw, Poland
03 Feb 2021
04 Mar 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Currently DOCS is looking for Trial Manager for our Client- well know Pharmaceutical Company.
Clinical Development Center Poland was established in January 2019 and is responsible for clinical trial conduct across 16 countries in Europe. This includes: Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Macedonia, Portugal, Romania, Serbia, Slovakia, Slovenia and Poland by providing clinical trial management and administration to Adjacent Affiliates.

Trial Manager in CDC Poland manages assigned clinical trials, leads the CDC trial teams in order to ensure high quality execution of the trials and deliverables within all countries in the CDC. TM enables the Adjacent Affiliate teams to deliver clinical trials in the shortest possible time in accordance with the internal policies and procedures, SOP's, local legislation and GCP requirements.

Essential responsibilities
•Overall project management of assigned clinical trials in the CDC and adjacent affiliates
•Responsible for deliverables and high-quality execution of clinical trials in the CDC and adjacent affiliates
•Leading the CDC trial teams
•Planning, executing, coordinating tasks and communicating between relevant roles, such as CDC CTA and CRAs in adjacent affiliates and global trial management, to facilitate the progress of the trial
•Attending all trial related meetings / TCs and ensuring knowledge sharing across the CDC trial team
•Proactive risk identification and executing mitigation plans at the CDC level and adjacent affiliates
•Ensuring successful start-up of clinical activities in the CDC and adjacent affiliates (all trial related documents review, CTA dossier oversight, ensure timely HA/EC submission/approval, ensure materials for site initiation / selection, e.g. preparing presentations)
•Responsible for trial budgets (ClinCost): preparation and tracking in the CDC and adjacent affiliates
•Execute and follow up on Recruitment and Retention plans at the CDC level and adjacent affiliates
•Perform Visit Report review (all type of visits)
•Conduct co-monitoring visits across the CDC
•CTMS set-up & update at country level (for adjacent affiliates)
•Oversight and compliance check of STMF (nD/Veeva) for assigned clinical trials in close collaboration with CDC CTA
•Supervise clinical supplies' processes in the CDC and adjacent affiliates, e.g. ordering, handling ancillary, import-export process
•Report timely on quality issues
•Audit readiness, audit action plans and follow up for assigned clinical trials in CDC
•Inspection readiness and inspection action plan for assigned clinical trials in CDC

•Master level of education
•Fluency in English - written and spoken
•Minimum 5 years of experience in operational aspects of planning and conducting in clinical trials
•Minimum 1 year (preferably 2 years) of experience in project management of clinical trials at local/regional level (e.g. multi country set-up)
•Proven experience of successful collaboration in multi-national environment Proven decision making and problem-solving capabilities
•Ability to work in changing environment to be agile and proactively finding efficient ways of doing things
•Excellent communication skills - ability to communicate and build relationships with various stakeholders
•Team oriented personality with high degree of flexibility and cross-cultural awareness
•Presentation and negotiation skills

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