Job Description
Senior Manager Clinical Outsourcing Hybrid
Description
Under the direction of the Sr. Director, Clinical Outsourcing, the Senior Manager, Clinical Outsourcing will lead and manage the clinical trial outsourcing, vendor selection and contract negotiation, vendor management, and reporting process for the company's clinical development programs. This role will be Instrumental in the management of external partnership outcomes for clinical trials, including coordination and management of service providers and other outsourcing needs. Responsibilities include clinical CRO/vendor identification, RFI/RFP development and execution, vendor selection, contract negotiations, budget management and service provider performance metrics development and tracking.
Responsibilities
35% Vendor selection and contract negotiation:
Guides project teams through the outsourcing process and gives appropriate suggestions and advice on the best approach / best practices
Guides and participates in the evaluation, selection, and negotiation of contracts for assigned studies/programs.
Works with Project Managers and Project Teams to develop RFPs.
Works with Project Managers and Project Teams for all operational, scheduling, project budget and cost-saving considerations for assigned studies/programs.
Liaises with project teams to develop the Statement of Work (SOW) for each contract; coordinates the SOW review and finalization process.
Negotiates new and amended work specifications, budgets, payment schedules, relationship management plans, and other documents that control the activities and performance of contract service providers.
25% Vendor management: 15 25 Vendor per study
Participates in scheduling, organizing, and facilitating kickoff meetings with vendors.
Participates team meetings with vendors.
Supports the project teams to assure the quality and timeliness of deliverables through outsourcing.
Monitors and manages relationships with contracted vendors; facilitates the resolution of issues and conflicts.
Supports organizational governance activities with vendors.
Works with Project Teams to ensure outsourced clinical trial activities meet quality standards and expectations and adheres to applicable Corporate SOPs, WPs, policies, guidelines, and regulations.
Ensures smooth and effective communication between the vendors and the company.
Ensures Vendors/CROs are accountable and Identifies issues and develop solutions
Facilitates the closure of each study/contract with the vendor, including a mutual assessment of performance.
30% Support Outsourcing Team
Locate Statement of Work (SOW) for each study level agreement; save the working documents as well as final contracts to the Clinical Outsourcing folder.
Ensure consistent naming convention
Review CRO Contract & populate category spend to allow for analysis
Ability to Liaise with project teams, CROs and Vendors
Ability to search Contract Management System
Create Vendor Contract Trackers for each study and update with contract data and terms
Collect and analyze data from CRO contracts
Setup Outsourcing Onboarding guidelines.
Support the development of templates and save to Outsourcing folders.
Setup cost-saving excel file.
Assist with creating clinical trial budgeting models and what-if scenarios for future trials
Assist with FP&A needs related to clinical vendors, including annual budgeting, periodic forecasting, and monthly budget vs. actual analysis
10% Cross-Functional Support
Assist with creating clinical trial budgeting models and what-if scenarios for future trials
Assist with FP&A needs related to clinical vendors, including annual budgeting, periodic forecasting , and monthly budget vs. actual analysis
Core technical skills
Demonstrated expertise in forecasting, budgeting, data analytics, modeling, and process improvement design.
Pharmaceutical portfolio experience across teams, collaborating with Clinical Operations, Cost Management, Finance and Procurement functions
Vendor and or clinical CRO oversight experience, ensuring execution within budget, on time, and of the highest quality
Must have extensive experience managing CROs, central laboratories, and other clinical study vendors, including trial sites
Positive management style, combined with superior communication skills and unwavering ethics and integrity
Strong interpersonal skills with demonstrated ability to connect, collaborate and build relationships across all levels and functions and establish credibility with leaders and key external stakeholders
Strong oral and written communication skills with ability to communicate effectively at all levels and present complex and/or new ideas both internally and with external stakeholders
Extensive knowledge of GCP and ICH principles of clinical trial conduct
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). Microsoft Project a plus.
Qualifications
BA or MS in relevant discipline
Minimum of 5 years clinical outsourcing experience
Job Tags
Permanent employment, Contract work,