Clinical Operations Manager (FSP) - Russia, Moscow - Permanent Contract - Sponsor Office based opportunity
Clintec is actively recruiting for a Clinical Operations Manager (FSP) to join our expanding global company in Russia, Moscow – this is a Permanent Office based opportunity. The successful candidate will work fully assigned to one of our sponsors, a top 5 pharmaceutical company. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.
The Clinical Operations Manager (FSP) will be accountable for the execution and oversight of local operational clinical trial activities in Country. The COM will also be responsible for local regulatory and financial compliance for assigned protocols.
Responsibilities of the Clinical Operations Manager (FSP):
- Take ownership of country and site budgets
- Develop, negotiate and complete of Clinical Trial Research Agreements (CTRA)
- Oversee and track clinical research-related payments
- Perform reconciliation of payments at study close-out
- Track financial forecasting of the operational budget in conjunction with Clinical Research Director
- Execute and oversee the clinical trial country submissions and approvals for assigned protocols
- Develop local language materials including local language Informed Consents and translations
- Manage country deliverables, timelines and results for assigned protocols to meet country commitments
- Collaborate closely with Regional Operations to align country timelines for assigned protocols
- Provide support and oversight to local vendors as applicable
- Oversee and coordinate local processes
- Manage supplies, drug supplies and supplies destruction, importation and exportation requirement, archiving and retention requirements, and insurance process
- Maintain country information in clinical, regulatory, safety and finance systems
- Educated to Bachelor's Degree (or comparable) in Business Finance, Administration, Life Science or equivalent Health Care related experience
- 5-7 years’ clinical research experience
- Extensive experience in clinical project management and coordination
- Expertise of core clinical, regulatory and financial systems, tools and metrics
- Extensive knowledge of local regulatory environment and submission and approval processes
- Strong communication and leadership skills
- Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal
- The ability to focus on multiple deliverables and protocols simultaneously is essential
- Ability to work effectively also in a remote virtual environment with a wide range of people
- Fluency in English and Russian
- Ability to work office based in Russia, Moscow
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.