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Senior Clinical Site Contracts Analyst - FSP / Sponsor Dedicated

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Job IDR0000009176 Southeast - Remote - United States of America

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 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

Other:

• Develop written processes relevant to the scope of work listed above as needed

• Contribute to team efforts for continuous process improvements

• Adhere to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable.

• Participate in the development and testing of relevant tools and procedures

• Workflow management

• Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training

• Adhere to EP and Client SOPs and processes

Skills and Education:

*APAC experience is required

• 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

#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.