Site Contracts Lead - US/LATAM - Remote

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Requirements:

• Mastery in negotiating complex contract terms with clinical sites and vendors
• Excellent verbal and written communication skills to interact with internal stakeholders, clinical sites, Sponsors, and regulatory authorities, if required.
• In-depth understanding of international and local regulatory requirements for clinical trials (e.g., FDA, EMA, ICH-GCP).
• Ability to explain complex contract terms clearly and concisely
• Leadership skills to guide and support junior contract specialists
• Ability to collaborate effectively with cross-functional teams, including but not limited to legal, finance, data protection and clinical operations.
• Bachelor's Degree or equivalent in business administration, finance, science or related field.
• Excellent verbal and written English language skills.
• Proficiency with MS Word, Excel and Outlook
• 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 the biopharmaceutical/CRO industry and applicable local regulatory requirements.

Responsibilities:

• Main point of contact for the Project Team and Sponsor, for all Study site contracting activities, during the life of contracting on the Study.
• Serves as a Lead and Subject Matter Expert (SME) on Clinical Trial Agreement processes at the Study level and in accordance with the Contract and Budget Plan (CBP), outlining a strategy for the contract negotiation process and responsibilities.
• Presents sites contract negotiation processes during Alignment / Launch meetings and provides update during internal and external team meetings until finalization of contracting activities.
• Communicates and facilitates site contracting strategies, contract turnaround/execution timelines, and sites contract tracking requirements.
• Accountable for Study level site contracting tracking tools completeness
• 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.
• Responsible for ensuring the timely delivery of Study site contracting updates to stakeholders
• Recognizes potential problems/areas of concern and formulates contingency plans during the Clinical Trial Agreement development and escalates appropriately.
• Develops and implements mitigation plan to ensure the Clinical Trial Agreement deliverables are met.
• Works closely with the Global Project Lead, Site Activation Manager, Regulatory Affairs Manager and/or other departments/Leads to ensure delivery of fully executed agreements in support of timely Study site activation deliverables to meet departmental goals.
• Maintains a working knowledge of, and ensures compliance with applicable ICHGCP Guidelines, local regulatory requirements, Worldwide SOPs and project specific procedures; maintains and assures quality of work generated.