Ref #: 29783

Employment type: Permanent - Full-Time

Location: Any location in Poland

Posted: 07-Jun-2021


The Clinical Trial Manager will be responsible for leading the regional matrix team, including CRAs, CTAs and additional staff, to ensure delivery of country and site level study activities in alignment with the global study project plan.

Key Responsibilities include:
•Identifying and resolving issues at a regional level
•Collaborating with Global PM to ensure country level study delivery is aligned with the global study project plan
•Contributing to study-level risk assessments
•Leading and continually review regional risk mitigation activities to ensure study delivery to plan
•Overseeing regional insourcing /outsourcing partner deliverables to the required standards
•Partnering with Tech Services, Supplier Governance and Electronic Trial Operations to ensure regional, country and site vendor set-up, conduct and quality
•Leading regional documentation and required tool and systems set-up
•Contributing to regional aspects of Drug Supply Plan
•Ensuring implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines

Critical Success Factors for the Role include:
•Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and applicable international regulations and guidelines
•Strong Knowledge of Clinical Development process and procedures
•Project planning experience including oversight of study deliverables, budgets, and timelines
•Ability to use scientific and clinical knowledge to conceptualize study designs
•Experience anticipating and resolving problems
•Experience writing and presenting clearly on scientific and clinical issues
•Experience collaborating and leading cross-functional teams (team /matrix environment)
•Knowledge of project risk management assessment and mitigation approaches

Requirements and Qualifications:
•BA/BS/BSc or RN
•At least one year of experience on the similar position
•General biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
•Previous management experience of direct reports
•Experience in oversight of outside clinical research vendors including CROs, central labs, imaging vendors, etc.

Key Competencies:
Project Management / Risk Assessment / Critical Thinking and Planning / Matrix Team / Organizational Leadership / Metrics Analysis / Strong Written and Oral Communication / Delivery Focus / Decision Making / Relationship Management / Conflict Resolution / Problem Solving / Adaptability / Flexibility / Working in Virtual Teams

Why Join DOCS?

If you are an experienced clinical professional looking for an opportunity with a rapidly growing and fast paced global leader on an interesting and complex project this would be a compelling role for you. To express your interest please reply to this role and contact: Dagmara Drozdowska; at: /+48668870261