Senior Manager, Clinical Outsourcing
Position: Senior Manager
Location: Sun - Princeton - Corporate Office
Company: Sun Pharmaceutical Industries, Inc (USA)
Job Summary: The Senior Manager, Clinical Outsourcing is responsible for managing the clinical trial outsourcing, vendor selection, contract negotiation, vendor management, and reporting process for Sun Pharmaceutical’s clinical development programs. Reporting to the Sr. Director of Clinical Outsourcing, this role will oversee external partnership outcomes for clinical trials, coordinating and managing service providers and other outsourcing needs. Key responsibilities include CRO/vendor identification, RFI/RFP development, vendor selection, contract negotiations, budget management, and service provider performance tracking.
Responsibilities:
Vendor Selection and Contract Negotiation (35%):
Guide project teams through the outsourcing process, providing recommendations on best practices.
Participate in the evaluation, selection, and negotiation of contracts for assigned studies/programs.
Collaborate with Project Managers and teams to develop RFPs, considering operational, scheduling, budget, and cost-saving factors.
Liaise with project teams to develop Statements of Work (SOW) and coordinate review and finalization processes.
Negotiate new and amended work specifications, budgets, payment schedules, and other documents controlling service providers' performance.
Vendor Management (25%):
Participate in scheduling, organizing, and facilitating vendor kickoff meetings.
Support project teams in assuring quality and timely deliverables through outsourcing.
Manage relationships with contracted vendors and resolve any issues or conflicts.
Ensure outsourced clinical trial activities meet quality standards and adhere to corporate SOPs, WPs, policies, guidelines, and regulations.
Ensure effective communication between vendors and Sun Pharma, holding vendors/CROs accountable.
Facilitate the closure of studies/contracts with vendors, including mutual performance assessments.
Support Outsourcing Team (30%):
Manage SOW documents for each study and maintain consistent naming conventions.
Review CRO contracts and populate data for analysis.
Liaise with project teams, CROs, and vendors to ensure smooth collaboration.
Create vendor contract trackers and update contract data/terms.
Assist in developing clinical trial budgeting models and what-if scenarios.
Support FP&A needs related to clinical vendors, including budgeting, forecasting, and monthly analysis.
Cross-Functional Support (10%):
Assist in creating clinical trial budgeting models and scenarios.
Provide FP&A support, including budgeting, forecasting, and monthly analysis related to clinical vendors.
Core Technical Skills:
Expertise in forecasting, budgeting, data analytics, modeling, and process improvement.
Experience in managing pharmaceutical portfolios across teams, collaborating with Clinical Operations, Cost Management, Finance, and Procurement.
Extensive experience in managing CROs, central laboratories, and clinical study vendors.
Positive management style with strong communication skills and unwavering ethics.
Strong interpersonal skills, with the ability to connect, collaborate, and establish credibility with stakeholders.
Knowledge of GCP and ICH clinical trial principles.
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook); Microsoft Project a plus.
Qualifications:
BA or MS in relevant discipline.
Minimum of 5 years of clinical outsourcing experience.
Compensation and Benefits:
Compensation varies based on geographical location and experience.
Eligible for Annual Performance Bonus Plan, company vehicle, and incentive bonus.
Employee benefits include medical, dental, vision coverage, life insurance, 401(k), flexible spending accounts, and employee assistance program.
Paid time off benefits including vacation and sick time.
Equal Employment Opportunity: Sun Pharmaceuticals provides equal employment opportunities for all employees and applicants for employment, ensuring no discrimination based on race, religion, sex, or other protected characteristics.
Notice to Agency and Search Firm Representatives: Sun Pharmaceuticals does not accept unsolicited resumes from agencies or search firms for this job posting.
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