Contract Specialist
The Contracting Specialist is accountable for coordination, preparation, and execution of clinical study contracts (PI, site, institution, MSA, local vendors, etc. as applicable) in a direct country or extended country group (OPC and satellite countries) in close collaboration with Study Start Up Managers, Clinical Project Managers and Finance Specialists in compliance with GCP/ICH and regulatory requirements. What you will be doing:
- Supports country SSU strategy in close collaboration with the Study Start Up Team Lead and the Study Start Up Managers to ensure SSU timelines and deliverables are met according to country contracts.
- Accountable for coordination, preparation and execution of clinical study contracts and amendments (PI, site, institution, MSA, local vendors, etc. as applicable) for a assigned projects.
- Tracks and oversees contract status including the dispatch and return of contracts.
- Negotiates financial & legal conditions, escalates issues as applicable.
- Single point of contact for local Legal and ERC (e.g, for EC submission if required by local regulation) and MSAs.
- Adheres to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.
- Bachelors degree in business administration, law, or a related field; advanced degree or legal qualification preferred.
- Minimum of 5 years of experience in contracts management, preferably within the pharmaceutical, biotechnology, or clinical research industry.
- Strong knowledge of contract law, legal principles, and regulatory requirements relevant to clinical trials.
- Excellent negotiation and communication skills, with the ability to build rapport and influence stakeholders at all levels.
- Detail-oriented with strong analytical and problem-solving abilities, capable of managing multiple contracts and priorities in a fast-paced environment.
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your familys needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Information :
- Company : ICON
- Position : Contract Specialist
- Location : Remote
- Country : US
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Post Date : 2025-04-19 | Expired Date : 2025-05-19