Senior Manager, Clinical Outsourcing

5+ years

Not Disclosed

Princeton Junction

10 Jan. 5, 2025

Job Description

Job Type: Full Time Education: BS/MS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Here’s a refined version of the job description for clarity and professionalism:

Job Title:

Senior Manager, Clinical Outsourcing

Company Overview:

Sun Pharma is the world’s fourth-largest specialty generics company, offering a diverse portfolio of Specialty, Generics, and Consumer Healthcare products. With over 40 manufacturing facilities worldwide, we deliver trusted, high-quality medicines to more than 100 countries. For over two decades, we have established ourselves as a leading player in the U.S. generics market and are rapidly expanding in the specialty branded space, focusing on dermatology, ophthalmology, and onco-dermatology.

Job Description:

Location: Princeton, NJ
Department: Clinical Outsourcing
Reports To: Senior Director, Clinical Outsourcing

Sun Pharma is seeking a Senior Manager, Clinical Outsourcing to lead and manage outsourcing, vendor selection, contract negotiation, vendor management, and reporting processes for clinical development programs. This critical role will ensure the successful execution of clinical trials through effective coordination of service providers and outsourcing needs.

Key Responsibilities:

Vendor Selection and Contract Negotiation (35%):

Guide project teams through outsourcing processes, offering best practices and tailored approaches.
Lead evaluation, selection, and contract negotiation for assigned studies and programs.
Collaborate with project teams to develop RFPs and integrate operational, scheduling, and budget considerations.
Draft and finalize Statements of Work (SOW) for contracts and oversee reviews and approvals.
Negotiate work specifications, budgets, payment schedules, and relationship management plans with service providers.

Vendor Management (25%):

Organize and facilitate vendor kickoff meetings and ongoing team meetings.
Monitor vendor deliverables, ensuring alignment with quality standards, timelines, and budget.
Act as a liaison between project teams and vendors to address issues and ensure accountability.
Facilitate contract closure and conduct mutual performance assessments with vendors.

Support Outsourcing Team (30%):

Maintain and organize SOWs and contracts in Clinical Outsourcing folders with consistent naming conventions.
Review CRO contracts and analyze spending categories for trend insights.
Develop and update vendor contract trackers, cost-saving tools, and budgeting models.
Support onboarding processes, template development, and outsourcing workflow optimizations.
Assist in FP&A activities, including annual budgeting, forecasting, and budget analysis.

Cross-Functional Support (10%):

Partner with clinical teams to build "what-if" budgeting scenarios for future trials.
Collaborate with finance teams for detailed vendor-related financial planning and analysis.

Core Technical Skills:

Expertise in forecasting, budgeting, data analytics, and process improvement.
Proven experience managing CROs, central labs, and other clinical study vendors.
Strong knowledge of GCP and ICH principles for clinical trial conduct.
Advanced proficiency in MS Office, including Excel, Word, PowerPoint, and Outlook. Knowledge of Microsoft Project is a plus.
Ability to oversee vendor activities, ensuring timelines, budgets, and quality standards are met.

Core Leadership Skills:

Leadership: Effective team management and cross-functional collaboration.
Strategic Thinking: Ability to align outsourcing strategies with organizational goals.
Analytical Skills: Proficiency in analyzing complex data and deriving actionable insights.
Problem-Solving: Capability to address challenges with innovative solutions.
Interpersonal Skills: Demonstrated ability to foster relationships with internal teams and external partners.
Culture Advocacy: Commitment to promoting continuous improvement, professional growth, and inclusion.

Qualifications:

Education: BA or MS in a relevant discipline.
Experience:
- Minimum of 5 years in clinical outsourcing.
- Extensive experience managing CROs, central labs, and clinical vendors.
- Demonstrated success in contract negotiation and vendor oversight.

Compensation & Benefits:

Base Compensation: To be determined based on location and experience.
Incentives: Participation in the Annual Performance Bonus Plan and eligibility for a company vehicle and bonus compensation.
Benefits: Comprehensive benefits include medical, dental, vision, life insurance, disability insurance, 401(k), flexible spending accounts, and employee assistance programs. Paid time off includes vacation and sick leave.

Note: Compensation and benefits are subject to applicable plans, policies, and agreements. Sun Pharma reserves the right to adjust compensation based on individual performance, market factors, and other criteria.

Equal Opportunity Employer:

Sun Pharma provides equal employment opportunities for all employees and applicants, ensuring non-discrimination based on race, religion, gender, age, disability, or other protected statuses.

Notice to Agencies and Search Firms:

Sun Pharma does not accept unsolicited resumes from agencies or search firms. Submissions without a signed agreement become the sole property of Sun Pharma, and no fees will be paid for placements resulting from such submissions.

Let me know if this version works or if further adjustments are needed!

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Senior Manager, Clinical Outsourcing

Job Description

Job Title:

Company Overview:

Job Description:

Key Responsibilities:

Vendor Selection and Contract Negotiation (35%):

Vendor Management (25%):

Support Outsourcing Team (30%):

Cross-Functional Support (10%):

Core Technical Skills:

Core Leadership Skills:

Qualifications:

Compensation & Benefits:

Equal Opportunity Employer:

Notice to Agencies and Search Firms:

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