Responsible for adherence to standard operating procedures (SOPs). Perform the following, with minimal guidance from line management or more experienced colleagues: daily tracking, negotiation and approval of Site Agreements and Site Agreement templates (as applicable) for clinical study teams; timely updating of the departmental Site Agreement Management System ("SAMS") or any other system required for use on a particular study. Identify and escalate issues (as defined in departmental processes) 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 otherwise according to specified Sponsor requirements. Responsible for the timely updating of the departmental contract tracking system. Performs contract administration functions including: assisting with obtaining approvals on authorization forms as required; maintaining a contract tracking system to report contract status updates and signing status; providing notice of all executed contracts to the appropriate team members along with contract values; and scanning and filing 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. Provides management with regular status updates on all open contracts and any outstanding issues. Complies with and fulfils corporate requirements of the position including, inputting activities in Timesheets, conducting all required training and documenting training in training systems, and preparing and submitting any company expense reports for reimbursement in a timely manner. Drafts, negotiates, reviews, and processes contracts in a commercially reasonably manner that protects Covance's fundamental interests and in accordance with departmental practices and policies. Produces and negotiates contracts that accurately reflect Covance's obligations or rights and understandings with third parties. Negotiates contractual terms with other contracting parties in a professional manner. Ability to apply knowledge of the principles of ICH GCP to their work and follow quality standard procedures. Identifies potential obstacles in the contracting process promptly and requests assistance of line manager, project management staff, Business Development staff, Budgets & Proposals staff or higher management as necessary to minimize delays and to facilitate the prompt conclusion of contractual negotiations. Works closely with appropriate staff to keep them informed of progress of agreements and to avoid any delays in execution. Provides support to other Site Agreements staff and assists internal staff with contractual inquiries as required. Facilitates the internal review/revision/sign off process on contracts prior to forwarding to external parties. Coordinate and communicate with clinical study teams in a timely manner regarding contract details and timelines, as well as contract status reporting to ensure quick approval of templates and contracts. Support line manager with departmental goals, objectives and initiatives in a positive and flexible way. Assist in development and ongoing improvement of departmental processes and procedures. Perform other duties as required by the department.
Covance the drug development business of Labcorp the world's most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real.Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, along with our innovative technology solutions, help our clients identify new approaches and anticipate tomorrow's challenges as they evolve. Covance has supported the pharmaceutical industry to develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today.
We are currently recruiting for a Contract Specialist to join our team, as part of a global team you will be responsible for the preparation and negotiation of site agreements, confidentiality agreements, letters of indemnification and other contracts with study sites.
Candidates must have experience of preparing and negotiating site agreements, confidentiality agreements, letters of indemnification and other contracts with study sites.
Your main responsibilities will include, but not be restricted to:
Join us in our successful Site Start Up team and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers.
We can offer you not only a job, but a stable, long-term international career.
Bachelor's degree (LLB, JD, BA or BS) preferred, university-level law degree preferred (UK/EU)
Site contract negotiation experience at an international Biopharmaceutical or CRO environment.
Full business proficiency in English - both spoken and written is required for this vacancy.