About the role
FLSA Classification: Exempt, salary
Schedule: Monday to Friday, 8:00 AM – 5:00 PM
Department: Clinical Operations
Reports to: Sr. Director, Clinical Operations
Supervisory responsibilities: No
Location: Fully Remote
Position Summary/objective:
This position will provide support to the Clinical Operation team by guidance and oversight on tasks related to clinical contracts and budgets.
Essential functions:
Main responsibilities of this position include but are not limited to the following tasks:
Prepare, negotiate, analyze, escalate and finalize all required contracts and budgets with sites for US in conjunction with IP and Legal and/or outside counsel
Prepare internal investigator payment benchmarks
Use external investigator payment benchmarks to prepare site budgets
Identifies any potential risks for site contracting
Manage the overall site contracting timelines
Utilize legal as well as budget pre-accepted risk fallback positions to expedite negotiations
Ensure regular communication and escalations to expedite the planning, execution, issue resolution and management of Site contracts and other essential documents as required
Demonstrate a strong understanding of Site Activation requirements versus contracting turnaround times to support start up cycle times.
Act as escalation point for sites that are slow in negotiation budget and contracts
Reviews redlined site contracts and provide related support to less experienced negotiators.
Capable of drafting and negotiating complex site contracts, budgets and amendments confidently for USA.
Daily tracking and negotiation of Site contracts
Report current status internally to Clinical Operations as well as Legal
Assisting with obtaining approvals on authorization forms as required
Secondary functions:
Developing and maintaining SOPs, guidance documents & training material
Competencies:
Excellent verbal and written skills
Works independently
Strong communicator and collaborates effectively
Strong attention to detail
Flexible and able to work under pressure and meet project timelines
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