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