Clinical Outsourcing Specialist

Job Description

** W2 only - Not available for C2C or 1099 consulting **

** Must be local and able to work onsite 3 days/week **

Target Start Date:

September/October 2025

Position Overview

The Specialist, Clinical Outsourcing supports the planning and execution of clinical trial outsourcing activities. This role focuses on coordinating vendor contracts and financial processes, ensuring accuracy, compliance, and timely delivery. The Specialist collaborates with cross-functional teams - including study management, clinical operations, finance, quality and legal to assist in managing external service providers that support our Partners clinical programs.

Contracting & Vendor Support

• Assist in the preparation, routing, and tracking of study-level contracts, amendments, change orders, and related documentation under the oversight of the Associate Director.
• Coordinate with vendors, Legal, and Finance teams to ensure contracts are accurate, complete, and executed in a timely manner.
• Maintain trackers and documentation related to vendor agreements and study outsourcing activities.

Budget & Financial Coordination

• Support the preparation of budget documents and payment terms, ensuring consistency with study needs and corporate guidelines.
• Assist with purchase order (PO) requests, invoice processing, and budget reconciliations.
• Monitor contract spend against forecasts and escalate discrepancies to the Associate Director.

Cross-Functional Collaboration

• Provide administrative and logistical support to Study Management Teams (SMTs) to ensure outsourcing deliverables align with study timelines.
• Coordinate with Legal, Finance, Clinical Operations, and Quality to facilitate smooth outsourcing processes.
• Participate in team meetings and provide updates on contract status, budgets, and outstanding vendor actions.

Vendor Oversight Assistance

• Support tracking of vendor deliverables and performance against contractual obligations.
• Assist in gathering information for vendor evaluations.

Compliance & Documentation

• Ensure all contracts, budgets, and outsourcing activities adhere to internal SOPs, policies, and ICH/GCP guidelines.
• Maintain accurate records and documentation for contracts, payments, and vendor correspondence.

Process Support

• Assist with developing and updating outsourcing templates, trackers, and tools.
• Provide administrative support for continuous improvement initiatives within the outsourcing function.
• Contribute to team knowledge sharing by maintaining accurate records and distributing updates as needed.

Key Qualifications:

• Demonstrated experience in clinical research outsourcing within the pharmaceutical industry
• Experience supporting clinical study vendor oversight, including contract and budget negotiation

Education:

• Bachelor’s degree in a relevant field preferred (Life Sciences, Clinical Research, etc.)

Knowledge, Skills, and Abilities:

• Ability to manage and communicate effectively with vendors including negotiating contracts, analyzing scope of work, performing financial analysis, responding to inquiries and complaints
• Knowledge of global regulatory/industry guidelines (e.g. ICH/GCP) and interest in clinical trial operations
• Ability to complete tasks to deadlines and support the clinical operations team in doing the same
• Experience using DocuSign, MS Project, and other applicable computer and project management software
• Knowledge of rates, unit costs and costing structure, and site grants
• Proven ability to manage multiple competing priorities in a fast-paced global environment
• Strong written and oral communication skills with internal and external stakeholders
• Strong organizational skills and attention to detail
• High level of professionalism, integrity, and accountability