Site Contract Specialist II – Contract Manager II, Sponsor Dedicated

This is a fully remote position, open to applicants in Mexico, +2 more countries.

📋 Description

• Evaluate contract wording and budgets for thoroughness and precision, ensuring all necessary corrections are made and documented properly.

• Keep internal project trackers updated with accurate and timely details.

• Utilize fallback language provided by sponsors to negotiate site contract terms.

• Negotiate study budgets within set approval limits while adhering to escalation protocols.

• Participate in weekly internal and external progress meetings, offering updates and outlining next steps on ongoing contract negotiations.

• Work collaboratively with stakeholders to synchronize contract execution dates and site activation timelines.

• Build and sustain positive relationships with both internal and external stakeholders.

• Recognize contractual or operational risks early on and proactively implement solutions.

• Prepare contract and budget escalations when necessary.

• Draft and finalize documents related to study start-up, templates, and start-up plans.

• Organize and lead kick-off meetings with the study team.

• Schedule meetings for contract and budget preparation and review.

• Finalize contracts after negotiations are concluded and escalations are sanctioned.

• Engage in pilot and stretch projects that align with the role and sponsor initiatives.

• Assist in clinical studies from start-up to activation for a specific sponsor.

⛳️ Requirements

• Bachelor’s degree in Business, Public Health, Life Sciences, or a related discipline (or equivalent experience).

• At least one (1) year of hands-on site contract and budget negotiations experience within a CRO, site, or pharmaceutical company required for SCS-II/Contract Manager 2.

• Proven experience in independently managing Clinical Trial Agreements (CTAs).

• Experience in managing CTA amendments.

• Background in site budget negotiations.

• Familiarity with contract lifecycle management with minimal supervision.

• Strong grasp of CTA drafting and negotiation processes.

• In-depth knowledge of contract templates and fallback language.

• Strong understanding of budget development and negotiation tactics.

• Comprehensive understanding of clinical trial start-up procedures.

• Experience in maintaining negotiation status and documentation within Sponsor clinical trial tracking systems.

• Excellent knowledge of Phase II-IV clinical trials, ICH-GCP, and clinical development workflows.

• Strong project management, organizational, and prioritization capabilities.

• Exceptional negotiation, communication, and relationship-building skills.

• Proficient in Microsoft Office Suite.

• Preferred: prior experience supporting a Sponsor-Dedicated/FSP model.

• Preferred: experience in leadership or mentoring roles.

• Preferred: experience with a CRO.

• Preferred: experience in supporting process improvement initiatives within Site Start-Up or Site Contracts.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

• Collaboration with colleagues on a global scale.

• Flexible remote work arrangements.