Vendor Management Specialist

This is a fully remote position, open to applicants in Mexico, +4 more states.

📋 Description

• Oversee and manage third-party vendors on a daily basis throughout the entire clinical trial lifecycle.

• Collaborate with Study Management Teams, Functional Subject Matter Experts, Procurement, and the Biogen FSP Oversight Manager to develop vendor management plans specific to studies, Vendor Oversight Plans, and necessary vendor documentation.

• Create, gather, and finalize study vendor specifications in partnership with functional SMEs.

• Set, monitor, and fulfill study-level vendor timelines, deliverables, and contractual obligations.

• Provide updates to Study Management Teams on study advancements, vendor performance, risks, and issue tracking.

• Assess vendor performance through KPIs, governance meetings, and performance management reviews.

• Organize and lead vendor meetings, drafting agendas, minutes, and follow-up actions.

• Identify, evaluate, escalate, and mitigate risks associated with vendors.

• Foster cross-functional collaboration and problem-solving to ensure timely resolution of issues and successful study outcomes.

• Partner with Functional Quality Representatives to guarantee that vendor deliverables align with quality standards and study requirements.

• Ensure vendor compliance with GCP, ICH guidelines, regulatory mandates, Biogen policies, and company procedures.

• Facilitate effective communication and collaboration between vendors and internal study teams.

• Maintain precise vendor and study information within internal technological systems.

• Review vendor deliverables for any invoice discrepancies and alert the Clinical Trial Lead as necessary.

• Coordinate study-level vendor performance meetings and assist in managing vendor relationships.

⛳️ Requirements

• A minimum of 2 years of experience in Clinical Operations, Clinical Study Management, Vendor Management, or Clinical Operations Management within a Sponsor or CRO setting.

• Proven experience in managing clinical studies while balancing quality, timelines, and budget expectations.

• Demonstrated capability in managing third-party vendors and executing study-level vendor oversight activities.

• Proven track record of establishing and implementing vendor management plans tailored to study requirements.

• Strong skills in project management, risk assessment, contingency planning, communication, stakeholder management, and cross-functional collaboration.

• Familiarity with clinical study management across one or more clinical phases (Phase I, II, or III).

• Solid understanding and practical experience with Good Clinical Practice (GCP), ICH Guidelines, and global regulatory requirements for clinical development.

• Experience in monitoring vendor performance through KPIs, governance meetings, and issue escalation processes.

• A Bachelor’s degree or Associate's degree in a relevant field is preferred.

• Previous experience in overseeing third-party vendors within clinical studies is preferred.

• Experience with vendor oversight plans, study specifications, procurement teams, and vendor governance processes is preferred.

🏝️ Benefits

• Collaborate with global teams on cutting-edge clinical development programs.

• Work in an environment that prioritizes inclusion, collaboration, and continuous learning.

• Excellent opportunities for career development.

• Engage in meaningful work with prospects for a long-term career.

• Reasonable accommodations available to participate in the job application or interview process and to perform essential job functions.

• Equal employment opportunity provided to all applicants.