Company: Docs Global (Continental Europe)
Reference: Ref AS-019767
Closing Date: 06 Dec 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
DOCS has partnered with a highly prestigious organization with one of the most robust pipeline within the industry. A fantastic opportunity for an experienced clinical research professional that is ready to take on a new challenge, further develop their career and enjoy working culture.
Roles & Responsibilities of the position
- Act as liaison between Law Department, regional/country clinical operations personnel, and Management during issue escalation.
- Assist in coaching/mentoring staff members.
- Analyze the issue and manage the process in order to expedite resolution of complex legal issues in clinical trial contracting process.
- Track inquiries and monitor trends to identify need for additional standardized guidance and work with stakeholders to prepare such guidance for review/approval.
- Serve as facilitator for healthcare compliance policies in clinical trial contracting.
- Contribute in the capacity of subject matter expert to applicable intra-departmental functions to ensure consistency and compliance with process, external communications and policies (clinical trial agreements, confidential disclosure agreements, informed consent forms, etc.).
- Liaise with all members of clinical team as needed on complex and high risk issues in addition to representatives of investigator sites, academic research organizations, contract research organization, and site management organizations as directed.
- Lead/conduct contract negotiations on high risk terms and conditions and complex agreements and other relevant legal documents related to clinical trials.
- Responsible for independently coordinating assessments from stakeholders such as clinical team, law department, and internal team where appropriate to evaluate risks of legal terms and conditions.
- Liaise with legal and internal stakeholders as appropriate to prepare, organize and maintain contract templates in accordance with changes in laws, regulations, or corporate policies.
- We are looking for a person with minimum 2-3 years of experience (contract negotiation, risk assessments)
- Legal educational and professional background.
- By preference has been working in a pharmaceutical or CRO environment, clinical research or regulatory department.
- English mandatory
– knowledge of local language is an asset.
- Competitive salary and offer Social benefits
- Work in a global team
- Ability to work from any location
- As DOCS wants to keep a good work-life balance, we offer flexible working hours and some flexibility to work from home.
2 Globeside, Globeside Business Park
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