Site Contracts Lead, Europe
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Job Description
Site Contracts Lead overseeing clinical trial agreements and mentoring specialists. Collaborating with internal and external stakeholders to manage contracting processes efficiently.
Responsibilities:
- Be the main point of contact for Project Team and Sponsor, for all Study site contracting activities, during the life of contracting on the Study.
- Act as a Subject Matter Expert (SME) on Clinical Trial Agreement processes at country and site level.
- Agrees and negotiates Clinical Trial Agreements templates, fall back language and sites budget negotiation parameters with Global Project Lead and Sponsor.
- Supports, supervises, and mentors allocated Site Contracts Specialists, ensuring effective planning, effective communication, on time issues escalation, problem solving and execution.
- Negotiation and finalization or assistance in negotiation and finalization of Site Contracts with Worldwide Legal Department, project team, Sponsors, investigators and/or clinical sites, as well as amending and terminating such contracts.
- Accountable for maintaining the housing of all draft, finalized, and executed Study contracting documents within each Study Sharepoint.
- Creates and delivers on-going departmental trainings on various topics provided by contract management team.
Requirements:
- Up to 2 years of experience as a Principal Site Contracts Specialist and 2 – 3 years’ experience leading projects OR Minimum 6 years Site Contract experience in Clinical Research Pharmaceutical or CRO industry and 2 – 3 years’ experience leading projects.
- Bachelor's Degree or equivalent in business administration, finance, science or related field.
- Knowledge and understanding of ICH and GCP Guidelines, as well as local country legislation in the sphere of clinical trials and local regulatory requirements.
- High degree of organizational, analytical, and team management skills.
- Adept knowledge of biopharmaceutical/CRO industry and applicable local regulatory requirements.
Benefits:
- Professional development opportunities
- Flexible working arrangements
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