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Merck is looking for a Global Clinical Site Agreement (CSA) Lead that will be responsible to support the following activities as part of the Start-up Solution Unit Team:
Responsibilities
* Drive with internal and external business partners in developing the CSA Strategy Plan at study level
* Serve as CSA delivery expert for high priority studies and oversee the CSA delivery performance at study level
* Serve as the point of escalation to CSA team members and study teams on clinical site budget and agreement process issues and facilitate resolution to the issues.
* Ensure globally approved CSA templates are utilized at study level and coordinate the revisions of Master Clinical Site Agreement/Master Confidentiality Agreement templates and Legal Manuals.
* Lead, develop and update negotiating parameter guidance documents (which include agreed grant plan budget limit, contract language, apply forward terms and fixed item cost sheets) with internal and external business partners at Country and Site level (as needed) independently.
* Approve Fair Market Value (FMV) assessments for any complexity investigator grant evaluation across the portfolio independently
* Manage or approve high level estimates or budget build, for any complexity local regional CSS, CRS and global development trials at study, country or site level
* Perform Confidentiality Agreement customization across the portfolio and lead discussion with Legal where required; coordinate and lead Confidentiality Agreement escalation, evaluation and feedback across the portfolio
Please be aware that this position is remote, and we offer flexibility regarding the location.
Qualifications
* At least 10 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment
* Understanding of the overall clinical development paradigm, especially in the area of clinical study operations
* At least 5 years of experience in contract and budget negotiation at Global or Regional level (at least)
* Experience in oversight of external service providers, preferred
* Experience in the management of contracts related to additional HCP activities (e.g. SMC, IDMC,...), preferred
* Thorough knowledge of ICH-GCP and applicable laws and regulations for key countries
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