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Senior Manager, Clinical Outsourcing, Princeton, N - Hybridj

5+ years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Job Title:

Senior Manager, Clinical Outsourcing


Company:

Sun Pharmaceutical Industries, Inc (USA)


Location:

Princeton, New Jersey, USA (Hybrid)


Job ID / Posting Date:

Posted on April 21, 2025


Department:

Clinical Outsourcing Team


Employment Type:

Full-time


Reporting To:

Senior Director, Clinical Outsourcing


Role Summary:

The Senior Manager, Clinical Outsourcing will lead and manage all clinical trial outsourcing functions including vendor identification, RFI/RFP execution, contract negotiation, budget oversight, and vendor performance management for Sun Pharma’s global clinical development programs. This role is key in ensuring timely, quality deliverables from outsourced service providers and supports financial planning and cross-functional clinical operations.


Key Responsibilities:

Vendor Selection & Contract Negotiation (35%)

  • Guide project teams through outsourcing processes, best practices, and vendor strategy.

  • Lead RFPs, contract development, and SOW finalization.

  • Negotiate contract terms, budget, timelines, and deliverables.

Vendor Management (25%)

  • Manage 15–25 vendors per study.

  • Organize vendor meetings, track deliverables, and resolve issues.

  • Ensure compliance with SOPs and regulatory requirements.

  • Oversee vendor performance and relationship closure post-study.

Outsourcing Operations Support (30%)

  • Maintain SOWs, contracts, trackers, and category spend data.

  • Analyze vendor contract data and support budgeting and onboarding tools.

  • Develop templates, cost models, and support financial tracking tools.

Cross-Functional Support (10%)

  • Assist in clinical budgeting models and “what-if” trial scenarios.

  • Collaborate with FP&A for budgeting, forecasting, and variance analysis.


Technical Competencies:

  • Forecasting, budgeting, data analytics, and process improvement

  • Clinical vendor and CRO oversight experience

  • Strong knowledge of GCP, ICH guidelines

  • Skilled in Microsoft Office suite; MS Project is a plus


Behavioral Competencies / Soft Skills:

  • Strong interpersonal and collaboration skills

  • Excellent oral and written communication

  • High ethical standards and attention to detail

  • Ability to work cross-functionally with Clinical Ops, Finance, Procurement


Education & Experience:

  • Education: BA or MS in a relevant scientific discipline

  • Experience: Minimum 5 years in clinical outsourcing, preferably within the pharmaceutical or biotech industry