Senior Clinical Contracts Analyst

Position Purpose:

The Clinical Contract Analyst serves as a conduit between Clinical Operations and the Legal group for contract requests including Confidentiality Agreements, Clinical Trial Agreements (CTAs), Ancillary Services Agreements, Consultant Agreements and other clinical contracts.

Primary Duties:

Manage Clinical Contract and Nondisclosure Agreement (NDA) process for Global trials

Serve as a conduit between Clinical Operations and the Legal group for contract requests including Confidentiality Agreements, Clinical Trial Agreements, Ancillary Services Agreements, Consultant Agreements and other clinical contracts

Process all clinical contract requests and help facilitate early execution through the Contract Management System

Serve as primary contact for the Client during contract negotiation phase

Perform consistent quality audits of work output and document knowledge base as needed

Maintain contract tracking on SharePoint site and other systems used to manage contract and budget files

Negotiate Clinical Site Contracts & Budgets For Sites Managed by Sponsor:

Manage and own the contract process through its lifecycle from initial template stage to fully negotiated contract

Work closely with study teams to develop country budget templates tailored for each study

Negotiate and manage consistent site budgets that will assist in early site activation

Ensure consistency in site payment schedules and terms to facilitate the payment system

Respond to queries related to contracts and budgets

Manage the contract escalation process to appropriate individuals, as needed

Establish good customer relations with sites starting with the primary point of contact for budgets and contracts

Analyze contract trends using available tools and assist with developing team metrics with regard to contract timelines.

For Sites Managed by a Clinical Research Organization (CRO):

Review and approve the master Investigator Fee template developed by CRO for each study before distribution to sites

Manage the final execution of site clinical contracts handled by a CRO and track the contract process for each study with a CRO;

Serve as escalation point of contact for budget escalations from CRO;

Provide contract/budget comments to CRO on an as needed basis;

Respond to CRO queries for previously negotiated site contracts to ensure consistency with contract language and budget line items

Skills and Education:

Bachelor’s degree in Life Science, Business or equivalent. MBA preferred

Minimum four (4) years of global experience working in a biotech or CRO, finance and/or business environment as a contract analyst/specialist

Experience negotiating contract payment terms and budgets

Intermediate Excel and database management skills

Knowledge of GCP/ICH requirements

Excellent analytical and problem solving skills

Requires effective organizational and communication skills

Work both independently and ability to successfully work in a “virtual” team environment

Has a track record of exceeding goals successfully

Partners with others to get work done

Follows through on commitments

Shows personal commitment and takes action to continuously improve

Deals constructively with problems that do not have clear solutions or outcomes

Maintains a positive attitude despite adversity

Acquires data from multiple and diverse sources when solving problems

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