Senior Clinical Contracts Analyst

hace 3 semanas


En remoto, España Parexel A tiempo completo

In Parexel FSP we are looking for a Senior Clinical Contracts Analyst based in Spain.

**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 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
- Fluent English and Spanish is a must

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