Senior Clinical Contracts Analyst - Southeast, United States - Parexel

Description

Job Summary:

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 Client:

• 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 PXL, as necessary, including general training requirements, SOPs, and system and process related training

• Adhere to PXL and Client SOPs and processes

Skills and Education:

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

• Minimum four (5) years of global experience working in a biotech or CRO
environment in the site contracts space

• Experience negotiating contract payment terms and budgets with Asia Pacific or Latin American sites

• 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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