Senior Clinical Project Manager - Medivir AB - Avslutad
Medivir is a research-based pharmaceutical company with a current research and development focus within oncology, osteoarthritis and infectious diseases. The company has a leading competence within protease inhibitor design and nucleotide/nucleoside science and is dedicated to develop innovative pharmaceuticals that meet great unmet medical needs. Medivir is listed on the Nasdaq Stockholm Mid Cap List. You will be employed at Aktivia Science Work on a permanent position as consultant but will be placed and do all work and reporting within Medivir.
You will be part of Medivir Clinical Operations and will have responsibility for program lead and clinical project management for all operation activities within a program or project/projects. You will ensure a well-functioning study team and will be a contributor to strategic planning as well as to licensing and similar Business Development activities.
Key Profile Areas
- Constitutes the Clinical Project and/or Program Lead for all clinical operations activities within a specified project/program with responsibility for all aspects of clinical operations from planning and forecasting to execution, financial control, risk management and reporting
- Empowering team members to optimize performance in accordance with business objectives by ensuring a well-functioning high-performing clinical study team for timely delivery, building for quality and supporting innovation and scientific excellence.
- Leads and coordinates the development of clinical documentation including responsibility for documentation for specified clinical projects’ and/or programs’ operational activities in adherence to appropriate guidelines and Good Clinical Practice
- Contributor to the strategic planning of the specified clinical programs and responsible for the development and delivery of Clinical Development Plans for specified candidate drugs
- Manage all clinical outsourcing activities including negotiating and contracting with service providers in specified projects/programs
- Contributor to licensing and similar Business Development activities from a clinical project management perspective including estimates on clinical plans/risk assessment, budget and milestones.
- Represent Clinical R&D in cross-functional project teams and engages with the leadership to adopt and implement strategic initiatives according to plan and to drive clinical priorities in defined areas by contributing to develop a climate in teams of continuous improvement where effective and timely knowledge sharing and adoption of standards with positive influence on the Medivir culture and team colleagues.
- Key contributor to QA and compliance documentation for Clinical R&D including input to the regular maintenance activities
PhD in relevant natural science or medical discipline is a merit, master degree in relevant natural science or medical constitutes the minimum requirement.
Experiences and skills
- Several years of clinical study operations experience with substantial experience in project/program management roles
- Experience from different clinical phases of drug development driving accurate operational resource forecasting
- Track record in managing clinical risk plans
- Track record from operational strategy work
- Proven expertise within clinical development operational management
- Proven experience from clinical study monitoring
- Proven experience from clinical study budget management
- Excellent communication and medical writing skills
Good knowledge and ability in English and Swedish both in speech and in writing
More information and application
You are welcome to call Knut Natt och Dag at Aktivia Science Work on +46 722 16 68 00 if you have any questions concerning this position. Send your application with a short personal letter and your CV to firstname.lastname@example.org as soon as possible due to our on-going work with this recruitment. Write “CPM Medivir” in the e-mail subject field.
Aktivia Science Work is a recruitment and consultant company within Life Science specialised in positions within the Life Science industry – from early discovery through pharmaceutical development and clinical development to the market place. We are members in SwedenBIO and Medicon Valley Alliance. You can read more about us at our website, www.aktivia.se