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SUN PHARMA · 3 hours ago

Senior Manager, Clinical Outsourcing

Princeton, WV

Full-time

Onsite

Mid, Senior Level

$122K/yr - $174K/yr

5+ years exp

Sun Pharma is the world’s fourth largest specialty generics company, and they are seeking a Senior Manager, Clinical Outsourcing to lead and manage clinical trial outsourcing and vendor management. This role involves vendor selection, contract negotiation, and ensuring quality and compliance throughout the clinical development process.

Biotechnology

H1B Sponsor Likely

Responsibilities

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

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

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

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

Strong leadership and team management skills, with a track record of effectively leading cross-functional teams

Stay current with industry trends, emerging therapies, and advancements in clinical trial methodologies

Collaborative and able to build strong relationships with internal teams and external partners

Contributes to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion

Qualification

Clinical outsourcing experienceVendor managementContract negotiationBudget managementData analyticsGCPICH knowledgeLeadership skillsIndustry awarenessInterpersonal skillsProblem-solvingStrategic thinkingCommunication skills

Required

BA or MS in relevant discipline

Minimum of 5 years clinical outsourcing experience