Sr Manager, Investigator Grant & Clinical Contracting

5+ years

Not Disclosed

Princeton Junction

10 Jan. 5, 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

Sr. Manager, Investigator Grants & Clinical Contracting
Date: December 9, 2024
Location: Princeton, NJ (Hybrid)
Company: Sun Pharmaceutical Industries, Inc.

Sun Pharma is the world’s fourth-largest generics company with a diverse portfolio in Specialty, Generics, and Consumer Healthcare products. With over 40 manufacturing facilities worldwide, Sun Pharma delivers high-quality medicines trusted by healthcare professionals and patients in more than 100 countries. Over the past two decades, Sun Pharma has become a leader in the U.S. generics market and is expanding rapidly into specialty branded markets, focusing on dermatology, ophthalmology, and onco-dermatology.

This role is based in Princeton, NJ, with a hybrid work schedule: three days in-office and two days remote.

Position Summary

Sun Pharma is seeking a Sr. Manager, Investigator Grants & Clinical Contracting to join its Clinical Outsourcing Team in Princeton, NJ. Reporting to the Sr. Director, Clinical Outsourcing, this role will oversee clinical trial outsourcing, investigator grant budgeting, vendor management, contract negotiations, and related reporting for clinical development programs. The position also serves as a subject matter expert on Fair Market Value (FMV) assessments and investigator reimbursement processes, working closely with internal finance and accounting teams.

Key responsibilities include identifying vendors, managing RFIs/RFPs, developing budgets, tracking performance metrics, and ensuring adherence to corporate policies, GCP, and ICH guidelines.

Key Responsibilities

Investigator Grants (50%)

Analyze RFPs with a focus on protocol and synopsis details to determine investigator site and subject reimbursement costs.
Extract study-specific activities from clinical protocols to develop investigator grant estimates with support from Clinical Operations.
Validate grant budgets using internal and external benchmarking data.
Collaborate with cross-functional teams to ensure grant estimates align with study requirements.
Track cycle time metrics and other key performance indicators (KPIs) for investigator grant processes.
Research, compile, and maintain grant-related data to support decision-making.

Vendor Selection and Contract Negotiation (15%)

Lead project teams through the vendor selection and contracting process, providing strategic advice on best practices.
Develop and execute RFIs/RFPs, and coordinate Statement of Work (SOW) creation and finalization.
Negotiate contracts, including work specifications, budgets, and payment schedules, ensuring alignment with project goals.

Vendor Management (10%)

Facilitate vendor kickoff and team meetings to ensure quality deliverables and timelines.
Monitor vendor relationships, resolve issues, and support governance activities.
Oversee vendor performance evaluations and facilitate contract closures.

Outsourcing Team Support (15%)

Maintain clinical outsourcing documentation, including SOWs and contracts, ensuring consistent file naming conventions.
Create and update vendor contract trackers and analyze contract data for cost-saving opportunities.
Assist with clinical trial budgeting models, forecasting, and variance analysis.

Cross-Functional Support (10%)

Collaborate with Finance and FP&A teams to develop budgeting models, annual budgets, and forecasts.
Provide input for "what-if" financial scenarios to guide strategic decision-making.

Technical Skills & Competencies

Expertise in forecasting, budgeting, data analytics, and process improvement design.
Proven experience in vendor and clinical CRO oversight, including execution within budget and quality standards.
Strong knowledge of GCP and ICH guidelines.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and contract management systems; experience with Microsoft Project is a plus.

Leadership & Behavioral Skills

Strategic thinker with strong problem-solving and decision-making abilities.
Demonstrated leadership in managing cross-functional teams and building collaborative relationships.
Commitment to ethical standards and continuous improvement.
Ability to stay informed about industry trends and advancements in clinical trial methodologies.

Qualifications

Bachelor’s degree in a relevant field.
Minimum of 5+ years of experience in clinical outsourcing, with a focus on investigator grants and contract management.

Compensation & Benefits

This role is eligible for:

Annual Performance Bonus Plan.
Medical, dental, and vision insurance.
Life and disability insurance.
401(k) savings plan with employer match.
Flexible spending accounts.
Paid time off, including vacation and sick leave.

Equal Opportunity Employment

Sun Pharma provides equal employment opportunities to all employees and applicants, ensuring non-discrimination based on race, religion, color, national origin, sex, age, disability, sexual orientation, veteran status, or any other basis prohibited by law.

Agency Notice

Sun Pharma does not accept unsolicited resumes from third-party agencies or search firms. Resumes submitted without a signed agreement will become the property of Sun Pharma, and no fee will be paid.

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