Senior Manager, Clinical Outsourcing
1 week ago
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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