What are the responsibilities and job description for the Clinical Contract Specialist position at ProPharma Group?
At ProPharma Group, we are committed to empowering biotech, med device, and pharmaceutical organizations to advance scientific breakthroughs and introduce new therapies. As the world's largest RCO (Research Consulting Organization), our team partners with clients through an advise-build-operate model across the complete product lifecycle.
Job Description
The Senior Clinical Contract and Budget Specialist position is responsible for administering and negotiating site contracts that support clinical trial set up and execution on a global level. This role ensures site contract documentation follows sponsor and ProPharma requirements, works with internal and external team members to implement solutions for project and/or individual site contract-related problems, establishes strong working relationships with customers, internal project teams, and sites, and ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Responsibilities
- Administer all contract management processes from start of document draft, through final document completion, negotiations, agreement, and signatures.
- Support agreement on country template contract and budget.
- Lead negotiations of budget and contract with site and with inclusion of cross-functional teams as appropriate.
- Lead with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
Requirements
- Bachelor's Degree or International equivalent.
- Ability to understand, explain, and communicate contract concepts and put into detailed plans for progressing activities.
- Knowledge of FDA and/or applicable regional regulations, ICH GCP Guidelines, and any other applicable regulatory requirements that govern conduct of clinical trials.
