COSS-0, Associate Director, SSUL, Clinical Site Agreements
New Today
This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.Work your magic with us!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:ResponsibilitiesDrive with internal and external business partners in developing the CSA Strategy Plan at study levelServe as CSA delivery expert for high priority studies and oversee the CSA delivery performance at study levelServe 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 independentlyManage or approve high level estimates or budget build, for any complexity local regional CSS, CRS and global development trials at study, country or site levelPerform Confidentiality Agreement customization across the portfolio and lead discussion with Legal where required; coordinate and lead Confidentiality Agreement escalation, evaluation and feedback across the portfolioPlease be aware that this position is remote, and we offer flexibility regarding the location.QualificationsAt least 10 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environmentUnderstanding of the overall clinical development paradigm, especially in the area of clinical study operationsAt least 5 years of experience in contract and budget negotiation at Global or Regional level (at least)Experience in oversight of external service providers, preferredExperience in the management of contracts related to additional HCP activities (e.g. SMC, IDMC,...), preferredThorough knowledge of ICH-GCP and applicable laws and regulations for key countries
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- Location:
- City Of London, England, United Kingdom
- Job Type:
- FullTime
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New Today
COSS-0, Associate Director, SSUL, Clinical Site Agreements
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City Of London, England, United Kingdom
This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.Work your magic with us!Merck is looking for a Global Clinical Site Agreement (CSA) Lead that will be responsible to support the following activities as ...
More Details -
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New Yesterday
COSS-0, Associate Director, SSUL, Clinical Site Agreements
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City Of London, England, United Kingdom
OverviewCOSS-0, Associate Director, SSUL, Clinical Site Agreements – Merck HealthcareJoin to apply for the COSS-0, Associate Director, SSUL, Clinical Site Agreements role at Merck Healthcare.Work Your Magic with us! Ready to explore, break barriers, ...
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