Senior Manager, Clinical Outsourcing – Work Remote 1 Day Per Week
Based in NJ
To lead and manage activities related to the outsourcing of clinical services including negotiation, and maintenance of contracts for Clinical Research Organizations (CROs) and functional service providers for major Pharmaceutical Firm in New Jersey.Manage the processes which support the implementation and management of global outsourcing.Foster clear, consistent and open collaboration with Company and service provider staff to ensure the most optimal solutions are achieved. To engage in service provider relationship and performance management. To participate in continuous improvement initiatives which quicken or provide efficiencies in achievement of organizational goals.
- Support PCUs/CFUs 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 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 service provider performance issues
- Facilitate or attend lessoned learned meeting as necessary to incorporate improvements in new projects
- Manage assigned service provider relationships ensuring issue resolution and efficient outcomes, as applicable
- Monitor outsourcing environment to keep current on providers and industry trends
- Collaborate effectively with all relevant functional departments (e.g. Finance, Legal etc.) to ensure appropriate review and approval of clinical contracts.
- Maintain central database for contract tracking purposes, workload management, and metrics tracking.
- Identify best practices; lead the development and implementation of new processes for the department and other tasks that may be required to accomplish Clinical Outsourcing goals and objectives.
- Manage and/or mentor junior members of staff in outsourcing processes and in the review / QC of work as necessary
• 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).
• 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
• Highly organised 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
Compensation & Benefits :
- Company offers very competitive compensation and benefits package. Base Salary is $125-$130k, plus 15-20% bonus .
- Work Remote 1 Day Per week