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Senior Clinical Contracts Analyst
hace 2 semanas
Position Summary:
The Senior Clinical Contracts Analyst is responsible for managing the flow of clinical agreement lifecycles, negotiating clinical site budgets, and conducting business operations during the lifecycle of a clinical study as detailed below.
Principal Responsibilities:
Manage clinical contracts and Non Disclosure Agreement (“NDA”) process for global clinical trials:
- Serve as a conduit between Clinical Operations and the Legal group for contract requests including Non-Disclosure Agreements (NDA), Clinical Trial Agreements (“CTAs”), Ancillary Services Agreements, Consultant Agreements and other clinical contracts
- Draft clinical contracts and perform direct negotiation with contractual entities in accordance with negotiation playbooks
- Maintain the Contract Lifecycle Management System and clinical contract tracking system in real-time
- May serve as primary contact for Clinical Study Team and management regarding contract negotiation during the lifecycle of the study
- Attend Clinical Study Team meetings and provided status updates as required.
- Train and support team members on the clinical contracts process when necessary.
- Liaise with peers to drive forward clinical contracts
- Perform consistent quality audits of work output and document knowledge base as needed
- Maintain the Legal contract database and clinical contract tracking system in real-time
- Complete training assigned including general training requirements, Operational Procedures (“OPs”), and system and process related training
- Adhere to OPs and processes
- Contribute to clinical contract and Study Start-Up quality, systems, and process initiatives
Negotiate Clinical Site Contracts & Budgets:
- Works directly with sites for all aspects of study start up and amendment negotiations, including development of negotiation timeline, CTA review and coordination with legal, budget review and documentation collection and any necessary escalations to the Lead CCA or the study Clinical Contract Manager
- Monitors projected fully executed dates (PFEDs) (via internal systems or CRO reports) and escalates via standard pathways when PFEDs are at risk
- Manage and own the contract process through its lifecycle from initial template stage to fully negotiated contract
- Perform direct negotiation of clinical contracts with contractual entities in accordance with negotiation playbooks
- Negotiate and manage site budgets that will assist in early site activation. For countries with national budget templates, prepare budget using approved study budget on national template. 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 CRO:
- Manage the final execution of site clinical contracts handled by a CRO and track the contract process for each study with a CRO. Be a conduit for the contract requests to the Legal team from initial contract request through execution for contracts handled by a CRO and track the contract process for each study with a CRO
- 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
- Contribute to Clinical Contract Management and Study Start-Up quality, systems, and process initiatives
- Workflow management
Qualifications:
- Minimum five (5) years of global experience working in a Pharma, Biotech or CRO, finance and/or business environment as a contract analyst/specialist
- Experience negotiating contract language, payment terms and budgets
- Intermediate Excel and database management skills
- Knowledge of ICH/GCP in the provision of clinical trials
- Experience with CRO oversight preferred
- Experience with Oncology trials preferred
- Proficiency in English written and verbal communication
**Education**:
- BA/BS or equivalent or any relevant qualifying training
- Bachelor’s degree in business administration, Law or Accounting (preferred)
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