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Clinical Research Contracts Specialist
hace 2 meses
Job Summary
Esp Labcorp Development is seeking a highly skilled Clinical Research Contracts Specialist to join our EMEA Site Agreements team. This is a full-time and permanent position, which might be fully remote or office-based.
Key Responsibilities
- Ensure adherence to standard operating procedures (SOPs) and perform daily tracking, negotiation, and approval of Site Agreements and Site Agreement templates for clinical study teams.
- Timely update the departmental Site Agreement Management System (SAMS) or any other system required for use on a particular study.
- Identify and escalate issues that must be escalated to line manager for review.
- Confirm quality of tasks delegated to and completed by Contracts Associate.
- Manage assigned studies with careful compliance with internal processes and procedures, or according to specified Sponsor requirements.
- Responsible for the timely updating of the departmental contract tracking system.
- Perform contract administration functions including assisting with obtaining approvals on authorization forms as required.
- Maintain a contract tracking system to report contract status updates and signing status.
- Provide notice of all executed contracts to the appropriate team members along with contract values.
- Scan and file executed contracts in the shared electronic storage area in a timely manner for access by other staff members.
- Support line manager with departmental goals, objectives, and initiatives in a positive and flexible way.
- Provide management with regular status updates on all open contracts and any outstanding issues.
- Draft, negotiate, review, and process contracts in a commercially reasonable manner that protects Esp Labcorp Development's fundamental interests.
- Negotiate contractual terms with other contracting parties in a professional manner.
- Apply knowledge of the principles of ICH GCP to their work and follow quality standard procedures.
- Identify potential obstacles in the contracting process and request assistance as necessary to minimize delays.
- Work closely with appropriate staff to keep them informed of progress of agreements and to avoid any delays in execution.
- Provide support to other Site Agreements staff and assist internal staff with contractual inquiries as required.
- Facilitate the internal review/revision/sign off process on contracts prior to forwarding to external parties.
- Coordinate and communicate with clinical study teams regarding contract details and timelines.
Requirements
- Work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
- Minimum 0 - 2+ years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
- University/College degree.
- Fluent in local language and English.
