Clinical Trial Operations Manager
2 days ago
We are a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
We have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
- No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
Responsibilities:
- Lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
- Produce site-specific contracts from country clinical trial agreement (CTA) template.
- Negotiate budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
- Perform quality control and arrange execution of CTAs as well as archival of documents into repositories.
- Administer all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
- Generate amended contract and/or budget documents as necessary, preparing contract management documentation for projects.
- Work closely with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor's master service agreement terms.
- Identify possible contract or process operational risk and proactively work within the team to provide solutions.
- Support business development and represent site contracts/Site Start-Up (SSU) at internal or customer meetings.
- Collaborate with internal and external legal, finance, and clinical operations departments.
- Maintain and actively support review and development of contract templates, budget templates and site specific files and databases.
- Serve as key communication liaison between site contracts staff and internal and external customers.
- Train and mentor less experienced staff members on departmental Standard Operating Procedures (SOPs).
- Facilitate the execution of contracts by company signatories.
- Monitor basic financial aspects of the project and the number of hours/tasks available per contract.
- Review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner.
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