Clinical Operations Manager – Ukraine, Permanent, Home Based opportunity!

Company
Clintec
Salary
Competitive
Posted
15 Nov 2018
Closes
12 Feb 2019
Ref
EMEA-FTC-1714
Discipline
Clinical Research
Contract Type
Permanent

The Clinical Operations Manager 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:

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

 

Essential Criteria:

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 Ukrainian.

Ability to work home based in Ukraine. 

 

Company Information:

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. 

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