Global Site Contract Manager

Summary

Typically under the direction of a Global Site Contract Sr. Manager, the Global Site Contract Manager will oversee and manage the contract and budget negotiation at study level, supporting the Local Site Activation Associate(s) and Global Site Budget Analyst(s) assigned during the start up phase. The Global Site Contract Manager will work with Client Services, Legal, Business Development and Operations in the production and preparation of accurate, legally binding and effective Agreements that protect the interests of Pharm-Olam. As part of an ongoing contract management function, the Global Site Contract Manager will revise the text for site contracts after the specific out of scope work has been identified by the Project Manager/Global Site Activation Manager and approved by the Client. The Global Site Contract Manager will manage contracts through Pharm-Olam\'s internal approval process before these are sent to the Client. The Global Site Contract Manager will work with Legal in providing regular review of contract documentation and in the update, review and development of new templates, processes and tools to assist in the contract processes and to ensure contracts are in compliance with Pharm-Olam policies and procedures. This is a full-time, direct hire opportunity for an experienced candidate with site contracts / budget negotiation experience. Ideal candidate should be hands on and able to provideoversight on details and quality as well as adherence to the processes.

Responsibilities

• Attend the KOM and cover all aspects related to the Clinical Trial Agreement(s) and budget negotiation process as well as discussion and completion of the CTA questionnaire.
• Manage the development of Clinical Trial Agreement and Budget Plan (CTABP) that must be signed prior to the first site selection.
• Coordinate Site Contracts & Budgets with the Global Site Activation Manager/PM and Global Site Budget Analyst, managing negotiations with sites and internal teams (Local Site Activation Associates) according to study-level instructions; obtain sponsor approval on country-specific investigator budgets including escalation requirements.
• Provide sponsor with CTA questionnaire, general CTA template and fall back language.
• Provide Local Site Activation Associate(s) with approved CTA questionnaire, English general CTA template in track changes, and fall back language; incorporate into country templates when using Pharm-Olam contract template.
• Incorporate sponsor changes into the draft Country CTA templates and obtain sponsor approval; review and approve by Local Site Activation Associate(s) when using Pharm-Olam template.
• Review sponsor template and fallback language; share sponsor CTA template with Local Site Activation Associate(s) for local revision when using Sponsor template.
• Obtain sponsor approval for draft Country CTA templates when using Sponsor template.
• Train the team on CTA and Site Budget negotiation with the Global Site Budget Analyst.
• Obtain final draft of CTA and site budget approval at site level.
• Develop and maintain templates and tools to assist contract processes (e.g., template CDA, CTA).
• Participate in client contract negotiations, including group negotiation calls and direct client communication.
• Present at internal and/or external meetings including bid defenses; prepare and deliver presentations in collaboration with relevant departments.
• Escalate issues to appropriate stakeholders and perform other duties as required.
• Maintain working relationships: report to Global Site Activation Manager/PM; liaise with Legal, Client Services, BD and Operations; communicate with external clients during negotiations.

Qualifications

• Paralegal certification preferred or equivalent contract review experience.
• 5-7 years prior experience with pricing and contracts.
• Minimum 5 years\' experience in CRO/Pharmaceutical industry with understanding of clinical trial processes.
• Excellent computer skills and knowledge of CTMS systems.
• Strong written and verbal communication skills; ability to manage multiple projects independently.
• Strong experience in contract negotiations; technical writing experience is a plus.
• Experience working with cross-functional teams.
• Ability to travel domestically and internationally as required.
• A thorough understanding of the drug development process.

Working relationships

Report directly to Global Site Activation Manager/PM at a project level; liaise extensively with Legal, Client Services, BD and Operations; communicate with external clients as needed during the contracts negotiation process.