Clinical Team Manager (COM)

We are looking for a homebased 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. Furthermore, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure site readiness.
Responsibilities
Responsibilities include, but are not limited to:
· Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements '
· 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.
Qualifications
· At least 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 we do not sponsor work permits for this role.