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Job Details

Sr CGA

Company: Docs Global (Continental Europe)
Location: Prague 5 - Smichov,Czech Republic
Reference: Ref AS-025784
Closing Date: 25 Jul 18
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

This is an exciting opportunity to become part of a dynamic and successful international Biotechnology organization. The company is ranked in the global Top Pharmaceutical company and has seen very large growth on the market, thus you will have the chance to become an important part of their future growth and success. If you are looking for a new challenge, the chance to build a strong Contract and Grants career and you have the enthusiasm and drive to join a young and dynamic company,...

Requirements:

Roles & Responsibilities of the position

Responsible for analyzing contract requests/needs from operating companies and translating into appropriate contracts/budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects.
• Provide specialized support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required
• Analyze investigator grants for fair market value aligned with regional knowledge and the J&J grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information. Participate in and/or lead the approval escalation of grants as appropriate.
• Provide guidance to CROs contracted to negotiate CTAs globally, inclusive of training and supervision.
• Determine potential needs for contract amendments and manage amendment lifecycle.
• Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.
• Work with the global C&G team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language. Assess risks of budget and legal provisions in conjunction with members of the C&G team and support functions and communicate such to stakeholders. Liaise with C&G management, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.
• Assume responsibility for all aspects of legal document and metrics tracking.
• Review, authorize and/or manage payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
• Adhere to SOPs, ethics and departmental compliance as determined by CDO management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevan

Job Requirements

3- 5 years experience and/or equivalent competencies in pharmaceutical industry/clinical research
• Must have a working knowledge of the clinical development process with 2 years of negotiation and contract experience
• Excellent communication skills (both oral and written)
• Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.)
• Familiarity with clinical research processes
• Ability to work effectively in cross function teams
• Strong and proven negotiation and problem resolution skills
• Working knowledge of PCs (MS Office suite at a minimum)
• Fluency in English is required
• Must demonstrate innovative spirit, have strong interpersonal skills, and ability to accomplish substantial tasks with minimal supervision
• Previous experience working in virtual teams preferred.
Bachelor’s degree in appropriate scientific or business discipline

Remuneration & other details

- Strong, stable position in a large, international Biotechnology company
- Individualized coaching and development
- Dedicated training and education
- Competitive remuneration package

Apply for this job: Sr CGA

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Marlow
Buckinghamshire
SL7 1HZ
England
Website:  Visit Our Web Site

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