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Clinical Vendor Manager
Il y a 2 mois
Our US based pharmaceutical client is seeking to create a global team in Vendor management. This client is seeking a Client Vendor Manager to assist in vendor management across the country. This global team will focus on managing vendors for studies in GI, Oncology, Neuroscience, Rare Disease, Plasma Derived Therapies, and Vaccines.
CLINICAL VENDOR MANAGER
The Clinical Vendor Manager (CVM) is responsible for operational oversight of study specific vendors and is the primary project manager for end-to-end engagement with the Vendor alongside the Study Execution Team (SET) members, as applicable. This person may lead or support study operational strategy and planning and oversee execution of select activities within clinical studies (global/regional and/or local country) for assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan. This key manager will work in close collaboration with the Clinical Operations Program Lead (COPL) and the Clinical Operations Manager
KEY FUNCTIONS:
Lead/Manage the execution of vendors’ related activities within assigned clinical study/ies in compliance with quality standards (including ICH GCP, local regulations and SOPs), on schedule and on budget.
Responsible for Vendor Selection, Contracting, Management and Oversight
Generate, review, and finalize the Vendor Management Plan
Ensure vendor readiness, as agreed upon in the vendor SOW
Responsible for Day-to-Day Tracking of all vendors (e.g., eCOA, central lab, imaging, ) from Start-up to Study Closure
Oversee execution of vendor activities including risk identification, mitigation, management, escalation and follow-up
Support the Clinical Operations Representative with Vendor budget management and facilitate change order process
Perform appropriate onboarding of vendor teams/new team members
Responsible for Vendor Close-Out activities
Accountable for planning and operational strategy and execution for assigned clinical trials
o Oversee Vendor timeline management
o Challenges study team to ensure timelines meet the needs of the clinical development plan
o Ensures new team members and vendors are appropriately onboarded
o Identifies and oversees trial risk and mitigation o Leader of the cross functional study team
During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Education: Bachelor’s Degree or international equivalent required; Life Sciences preferred.
Skills:
Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
Experience in project/program management and matrix leadership o E.g. timeline/budget management o E.g. Risk identification and management
Experience managing multiple vendors, including selection, start-up, and oversight is required
Works independently and is highly organized
Excellent communication skills
Excellent teamwork, organizational, interpersonal, and problem-solving skills, including experience with Leading cross-functional teams
Preference: experience managing recruitment challenges and boosting enrollment
Fluent business English (oral and written)
**Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.
TRAVEL REQUIREMENTS: Requires approximately 5-20 % travel, including overnight and international travel to other sites, strategic partners, study sites, and therapeutic area required travel.