Clinical Team Manager (COM)
Pra International Sweden AB / Biomedicinjobb / Lund
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hela Sverige Visa alla jobb hos Pra International Sweden AB i Lund 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.
Publiceringsdatum2022-05-04Så ansöker duSista dag att ansöka är 2022-06-03
AdressPra International Sweden AB
Kolonivägen 1
22660 Lund
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Pra International Sweden AB (org.nr 556703-7394),
https://www.iconplc.com/ Kolonivägen 1 (
visa karta)
226 60 LUND
Ansökan E-post:
althea.sul@iconplc.com Jobbnummer 6606806
Observera att sista ansökningsdag har passerat.