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Clinical Trial Manager, Sweden
- Permanent
- Clinical Trial Assistant (CTA), Project/Study Manager (CSM/CPM), Program Manager / Director
- Sweden
This vacancy has now expired. Please see similar roles below...
Proclinical is in search for a remote Clinical Trial Manager for a world leading CRO located in Sweden. We are looking for a Clinical Trial Manager (COM) who is accountable for performance and compliance for assigned protocols in Sweden in compliance with IC H/GCP and Swedish regulations, sponsor policies and procedures, quality standards.
Job Responsibilities:
- Oversight of study finance- Payments, reconciliation, maintenance of financial systems and in conjunction with Project Manager participate in financial forecasting.
- Responsibility for creation and execution of clinical trial country submissions and approvals for assigned protocols.
- Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
- Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
- Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
- Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
Skills and Requirements:
- 5 + years' experience in Clinical Research or combined experience in Clinical Research and Finance/Business.
- Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.
- Expertise of core clinical systems, tools and metrics.
- Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
- Strong understanding of Swedish regulatory environment required.
- Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in Swedish and English.
- Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
- Right to live and work in Sweden. ICON does not sponsor work permits for this role.
If you are having difficulty in applying or if you have any questions, please contact Jon Stewart at +44 203 7520 318 or j.stewart@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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