- Provide primary outsourcing and vendor management support for functional areas supporting clinical trials, ensuring alignment with study and organizational objectives
- Interact closely with cross-functional teams to identify and meet outsourcing and contracting needs for clinical vendors, including CROs, laboratories, and specialty providers
- Lead the vendor identification, assessment, qualification and selection process for outsourced services, including preparing and managing requests for proposals, coordinating cross-functional review and assessment, performing qualification assessments and conducting budget analysis and negotiation
- Identify and promote cost-saving opportunities and spend conservation through close monitoring of out-of-scope cost adjustments with vendors and detailed review and negotiation of contracted budgets and change orders. Foster strong relationships with key vendors to achieve better pricing and more favorable payment terms. Ensure that all out-of-scope costs are properly authorized by relevant stakeholders and documented comprehensively
- Together with key team members, ensure vendor adherence to contract or individual scope of work throughout life of study
- Monitor and analyze vendor performance trends across individual functions and across multiple projects/programs. Perform quarterly oversight management and report to senior management.
- Contribute to the development and optimization of process, tools, and templates to improve overall outsourcing and vendor management practices. Train internal teams on best practices and new procedures
- Build and maintain strong, collaborative relationships with external vendors and internal stakeholders on clinical programs, serving as primary point of contact for vendors and supporting project teams in the resolution of vendor performance issues
- Bachelor's Degree in life sciences, business, or related field
- Minimum of 7 years' experience in clinical operations, outsourcing, procurement, or vendor management within the pharmaceutical, biotechnology, or CRO industry; equivalent combination of education and experience considered
- Proven experience managing clinical vendors and outsourcing activities for clinical trials
- Track record of establishing effective business relationships with internal and external customers
- Experience with vendor management best practices
- Strong knowledge of GCP, ICH guidelines, and relevant regulatory requirements
- Excellent negotiation, communication, and interpersonal skills
- Demonstrated ability to manage multiple projects and priorities in a fast-paced environment while remaining flexible, proactive, resourceful, and efficient
- Proficiency in MS Office Suite and collaboration platforms such as Sharepoint; experience with contract management systems a plus
- Must have ability to travel 15%.
- For this role, the anticipated base salary range: $136,000 to $170,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
- Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.
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Associate Director, Clinical Outsourcing and Vendor Oversight - Berkeley - Ray Therapeutics, Inc.
Description
Ray Therapeutics, Inc. is a clinical stage biotechnology company developing best-in-class vision restoration therapies for people with degenerative retinal diseases independent of genetic mutation. Reporting to the Vice President, Head of Clinical Operations, Science & Quality, the Associate Director, Clinical Outsourcing and Vendor Management is responsible for overseeing and facilitating the outsourcing of services and management of external vendors to ensure the successful execution of clinical trials. You will partner with clinical project teams and cross-functional leadership to assess key vendors and optimize outsourcing strategies, vendor selection, vendor oversight and relationship management for Tango's needs. This role is critical in ensuring that outsourced clinical activities meet organizational goals, regulatory requirements, timelines, and quality standards.
Key Responsibilities include but are not limited to:
Qualifications:
Compensation Range and Benefits:
At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
All employment is decided on the basis of qualifications, merit, and business need.
Search Firm Representatives Please Read Carefully
Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.
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