Overview
This role is for a Site Contract Specialist/Contract Manager (CM) supporting a Sponsor Dedicated environment. U.S. only (Remote). The position is responsible for negotiating and executing site contract and budget requests within the Genentech Global Pharmaceutical business units.
Responsibilities
- Review contract language and budgets for completeness and accuracy; ensure corrections are appropriately made and documented.
- Maintain internal project trackers with accurate and timely information to support overall transparency.
- Use sponsor legal-provided fallback language to negotiate site contracting language effectively and accurately.
- Negotiate study budgets utilizing the approved budget (medium and high) within approval parameters before escalation is required, following appropriate escalation pathways and processes.
- Attend weekly internal and external progress meetings; provide updates and next steps on active contract negotiations.
- Collaborate with primary stakeholders to ensure goals and priorities align with contract execution date and site activation timelines.
- Establish and maintain positive working relationships with internal and external stakeholders throughout the negotiation process.
- Identify contractual and operational risks early and proactively drive solutions.
- Prepare contract and budget escalations as required.
- Draft and finalize documents for studies-start up (templates, start up plans, etc.).
- Prepare for and lead the kick-off meeting with the study team.
- Schedule other contract and budget preparation and overview meetings.
- Prepare final contracts once negotiations are complete and escalations are approved.
- Participate in pilot and stretch projects as they align with the role and sponsor initiatives.
Requirements
- Bachelor’s degree in Business, Public Health, Life Sciences, or a related field (or equivalent experience).
- Demonstrated experience independently managing:
- Clinical Trial Agreements (CTAs)
- CTA Amendments
- Site budget negotiations
- Contract lifecycle management with minimal oversight
- Strong understanding of:
- CTA drafting and negotiation
- Contract templates and fallback language
- Budget development and negotiation strategies
- Clinical trial start-up processes
- Experience maintaining negotiation status and documentation within Sponsor or internal clinical trial tracking systems.
- Excellent understanding of Phase II–IV clinical trials, ICH-GCP, and clinical development processes.
- Strong project management, organization, and prioritization skills.
- Exceptional negotiation, communication, and relationship-building abilities.
- Proficiency with Microsoft Office Suite.
Preferred Qualifications
- Previous experience supporting a Sponsor-Dedicated/FSP model.
- Leadership or mentoring experience (Senior level).
- CRO experience.
- Experience supporting process improvement initiatives within Site Start-Up or Site Contracts.
Experience Leveling
- SCS-II / Contract Manager 2: Minimum of one (1) year of direct site contract and budget negotiations within CRO, site or pharma company required.
- Sr. SCS / Contract Manager 3: Minimum of two (2) years of direct site contract and budget negotiation required. Demonstrates strong skillset in overall contract and budget management/oversight and has a minimum of one (1) year of progressive experience leading site contract negotiations as client-facing point of contact within an industry sponsored clinical trial setting.
Compensation & Benefits
- Salary Range: $56,400.00 - $95,900.00
- Benefits may include:
- Company car or car allowance
- Health benefits including Medical, Dental and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time
- Paid sick time eligibility may vary depending on where you work due to regulated requirements by certain states and municipalities.
Location
- United States only (Remote).