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Job Title: Direct Hire - Senior Manager, Clinical Outsourcing
Work Location: Woodcliff Lake, NJ
Position Type: Permanent-Direct Hire
Client: A Big Pharmaceutical Company
The Senior Manager, Clinical Outsourcing will lead and manage with minimal supervision activities related to the outsourcing of clinical services including negotiation, and maintenance of contracts for Clinical Research Organizations (CROs) and functional service providers for the Oncology Business Group (OBG). Fosters clear, consistent and open collaboration with Client and service provider staff to ensure the most optimal solutions are achieved. Engages and leads service provider relationships to support performance management. Participates and leads continuous improvement initiatives which quicken or provide efficiencies in achievement of Client goals.
- Support Oncology Business Group (OBG) in the development of outsourcing requirements for Phase I-IV global clinical trials including functional services
- Lead and support the qualification and evaluation process for new service providers
- Lead with minimal supervision the process of Request for Proposal (RFP) development from service provider selection through final contract execution
- Manage the contracting activities including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, Change Orders, and Amendments
- Negotiate services descriptions, budgets and payment schedules using costing tools as necessary
- Facilitate study kickoff/familiarization meetings to clarify timelines, statement-of-work, roles and responsibilities, and budgets
- Support project teams in the resolution of study specific service provider performance issues
- Facilitate or attend lessoned learned meetings as necessary to incorporate improvements in new projects
- Manage assigned service provider relationships ensuring successful start-up and efficient outcomes, as applicable
- Monitor outsourcing environment to keep current on providers and industry trends
Scope of Work:
1. Collaborate effectively with all relevant functional departments (e.g. Finance, Legal etc.) to ensure appropriate review and approval of clinical vendor contracts.
2. Maintain central database for contract tracking purposes, workload management, and metrics tracking, provide regular updates as necessary
3. Identify areas for improvement and lead implementation of new department processes and other tasks that may be required to accomplish departmental goals and objectives
4. Mentor junior members of staff in outsourcing or other functions providing guidance on key processes. Regular QC contract documents as necessary
5. Act as subject matter expert or category lead for specified service areas
• BA/BS in scientific or business discipline required
• Direct experience (5 yr. minimum) in managing clinical contracts within the pharmaceutical industry within a clinical procurement/outsourcing function to include experience in the negotiation of contracts with Phase I-IV CROs, technical service providers, consultants etc.
• Demonstrates business/financial acumen and thorough understanding of CRO cost models and budget as well as services and costs associated with functional service providers (e.g. IVR, Central Labs, Biostatistics, and Medical Writing, Imaging, ECG, ePRO).
Skills and aptitude required:
• Must have excellent written and oral communication skills
• Team player able to form strong cross-functional relationships, demonstrating an ability to influence/persuade others
• Flexible and proactive
• Excellent analytical and problem solving skills with an eye for detail
• Strong understanding of financial and compliance standards
• Able to work with minimal supervision
• Highly organized with strong negotiation skills
• Must have good leadership and project management skills
• Thorough knowledge of GCP/ICH Guideline and Regulations
• Clear understanding of the drug development process
• Displays independent thinking and good judgment
• Proficiency in MS Office Suite.
Interested candidates can share their most updated resume at firstname.lastname@example.org or they can reach out to me on #973-967-3412
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