Clinical Contracts Analyst
- Experience Level
- Experienced (non-manager)
For our European operations Parexel FSP is currently looking for a Clinical Site Contracts Analyst who would perform their job responsibilities from their home office in Europe.
We will reward the right individual with a fully home-based, permanent role, excellent salary combined with a benefits package as well as many career progression opportunities.
The Site (Clinical) Contracts Analyst will be an integral member of the Clinical Development Operations (CDO) department, assisting with the entire life cycle of contracts activities, developing and negotiating clinical site budgets and conducting business operations as detailed below.
DETAILED DUTIES & RESPONSIBILITIES TYPICALLY INCLUDE:
- Manage Clinical Contract and Nondisclosure Agreement (NDA) process for Global Trials
- Serve as legal liaison for clinical contract requests such as, NDA’s, CTAs, Service Agreements, and Ancillary Agreements and act as conduit between CDO and the Legal group
- Process all clinical contract requests and help facilitate early execution through the Contract Management System
- Perform consistent quality audits of work output and document knowledge base as needed
- Maintain accurate contract metrics on an ongoing basis.
- Serve as primary contact for the Sponsor during contract negotiation phase
- On-going interface with sites and vendors regarding contractual issues during the lifetime of the contract
- Establish and maintain direct site and vendor contact
- Negotiate Clinical Site Contracts & Budgets
For Sites Managed by the 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 a budget template tailored for each study
- Negotiate and manage consistent site budgets that will assist in early site activation
- 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
For Sites Managed by a CRO:
- Review and approve the investigator fee template per country for each study before distribution to sites
- Be a conduit for the contract request to the Sponsor's team for initial contract request through execution for 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;
- Respond to CRO queries to ensure consistency with contract language and budget line items in accordance with Sponsor's standards
- 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 tools and procedures
- Workflow management
- Bachelor’s degree in Life Science, Business or equivalent
- Experience in contract management, proposal development or related field
- Intermediate Excel and database management skills
- Knowledge of ICH/GCP in the provision of clinical trials
- Excellent negotiation skills
- Highly organized with excellent oral and written communication skills
- Work both independently and as part of a team
For an immediate consideration, please send your CV to the job poster. We look forward to hearing from you