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Clinical Contracts Analyst II

Parexel International Corporation

Poland, Remote

Parexel FSP we are looking for a Clinical Contracts Analyst based in Poland.

Position Purpose:

The Senior 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:

  • 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 18 months 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

  • Fluent English and German is a must

Job posted: 2023-06-02