Primary ObjectiveProvide and manage key activities related to the outsourcing of clinical trials with a focus on vendor outsourcing. Establish and maintain program level oversight of clinical vendors and relationship management.Main Accountabilities:
Collaborate with internal stakeholders to determine vendor outsourcing and needs Lead the process for request for proposals for clinical operations and other internal functions such as Pharmacovigilance or Data Management. During the proposal process, work with Quality Assurance and the study or functional management teams to evaluate and select vendors. Selection process will include assessing vendor capabilities, as well as leading the study teams through the process of analyzing complex budget scenarios, bids, and outsourcing models to determine best value and best fit.Manage and schedule vendor capabilities presentations and bid defenses Provide input to internal team members and assist with tools and other means (scorecards, etc.) to assess potential vendors for capability, strategic fit, expertise, and performance with considerations on price. Manage and lead financial negotiations with external vendors to include review of scope of work and specification documents as well as liaise with legal on contract negotiations include CDAs, MSAs, change orders and LOIs. Will be primary point of contact to the vendors in resolving contract scope and financial issues for assigned studies/programs/vendors and managing and escalating issues accordingly.Manage vendor relationships and oversee vendor performance (including financial relationship management) to ensure compliance against contracted services for outsourced work and escalate issues as appropriate.Manage vendor financials for assigned in conjunction with the functional leads for studies/programs/vendor relationships including projected costs, tracking of unit utilization based on contracted activity, tracking of Purchase Order utilization.Evaluate and establish best practices with internal and external stakeholders and business relationships and represent Outsourcing in process initiatives.Establish escalation pathways with each vendor and maintain program level contacts at each vendor to discuss ongoing study managementAssist with compilation and management of vendor oversight process and vendor oversight plans. Provide oversight of vendors to ensure management of the project’s scope, contract, and finances; ensure that any contractual changes in scope are communicated, negotiated, documented, and transparently proportional to actual activity or incurred cost.Maintain current awareness of clinical outsourcing industry trends and contribute to process improvement and new process development.Mentor additional outsourcing team members as neededMay provide direct management support to additional team members.Preferred Qualifications:
Completed BA/BS in directly relevant discipline or equivalent experience required.6+ years experience and knowledge in clinical outsourcing and vendor management. Knowledge of ICH GCP guidelines and other regulatory requirements. Proficient in using Microsoft programs including Word, Excel, PowerPoint, OneNote, Teams and OutlookAble to prioritize and managing competing priorities. Team-oriented and excellent communication skills.
- Problem Solving
- Business Administration