Senior Manager, Clinical Outsourcing at Meet in Princeton, New Jersey

Job Description:

Position Summary:

The Manager of Clinical Contracts Management oversees all aspects of vendor selection, contracting, and negotiation for agreements essential to the clinical development plan. This role demands innovative problem-solving skills and experience with clinical research phases I-IV. Collaboration with clinical contracts team members, clinical trial teams, and vendors is crucial.

Responsibilities:

• Partner with clinical trial teams, internal stakeholders, vendors, and investigational sites to ensure timely study start-ups that align with departmental and organizational goals.
• Key duties include:
• Develop Investigator Grants budgets based on Fair Market Value benchmark data.
• Review RFPs for clinical services during the bidding process to assist in selecting CRO vendors, including budget development and contract negotiations.
• Represent Lilly's position on budget and contract matters, addressing issues in a frontline capacity.
• Manage contract escalations using the Negotiation Guidance Document and legal rationale, employing effective communication strategies.
• Handle budget escalations by applying Negotiation Parameters and standard pricing, providing justifications for Lilly's stance.
• Oversee and communicate the status of budget and contract finalization, essential for declaring a site ready for patient enrollment.
• Ensure CROs adhere to expected study timelines, collaborating with all team members to support study requirements and deliverables.
• Manage the development and execution of additional agreements as needed.
• Act as a liaison between clinical service groups (SMOs, CROs), legal teams, and clinical trial teams for outsourced trials when necessary.
• Navigate complex negotiations and resolve critical issues with external parties.
• Develop and apply innovative contract and budget strategies to address complex issues.

Basic Requirements:

• Bachelor's degree in business administration, finance, science, or a related field; equivalent work experience may be considered; advanced degree is a plus.
• 5-7 years of experience in pharmaceutical services, including at least 2 years in contract management or study start-up activities, encompassing contract negotiations and management.

Additional Preferences:

• Strong organizational, analytical, and team management skills.
• Proficiency in handling complex budgets.
• Competency in document and spreadsheet applications.
• Experience managing complex, multi-faceted projects.
• Demonstrated negotiation skills and extensive knowledge of clinical trial agreements.
• Proven ability to collaborate effectively with professionals across functions and teams.
• Excellent written and verbal communication skills.
• Ability to multitask and adapt priorities to meet tight deadlines.
• Professional demeanor, attention to detail, and organizational skills.
• Enthusiastic, self-motivated, and committed to improving processes and resolving inefficiencies.
• Proficiency in Microsoft Office Suite and applications.

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