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For more information speak to Tim Barratt on +44 (0)1727 817 626

To apply by email timb.25029.5174@keypeople.aplitrak.com

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Contract Management Specialist - 12 month contractRef: BBBH24698

Salary:£300 - £450 per day

Added:26 Nov 2019

Region: South East

Sector: Pharmaceutical

Sub Sector: Clinical Research

Within this role your responsibilities, as Contract Management Specialist, will involve being responsible for the timely and appropriate execution of Confidentiality Disclosure Agreements (CDAs), Clinical Study Agreements (CSAs), associated Budgets, and vendor agreements, the legal sections of the Informed Consents and issues on other legal, compliance, regulatory and policy matters (such as Insurance Policies, FMV, FCPA, etc.). *Serve as point person for their country/region for Legal, Finance, Site Management & Monitoring and Study Team. *Accountable for timely Preparation and Execution of CDAs, CSAs and Budgets and related vendor agreements, either directly or via local staff where a region is supported and language requires local help. Budgets should be in line with Country Fair market Value and actuals should be monitored. Deviations from Legally approved contract templates should be approved by Legal and should be in line with guidance provided by Legal. *Direct negotiation of CDAs, CSAs and Budgets with investigator sites using templates, guidance and Playbook from Legal where language is not a problem, or with the help of the Monitor where local language necessitates. Deviations from Legally approved contract templates should be approved by Legal and should be in line with guidance provided by Legal. *Input into legal aspects of informed Consents to ensure first pass acceptance or rapid resolution of issues using the Legal Playbook/guidance or Legal consult if necessary. *Setting, managing and communicating priorities to local affiliate stakeholders, Legal, and Finance in alignment with Study Plans and priority for start-up. *Provide input into ongoing update of the Playbooks and Templates with Legal. *Tracking CDAs and CSAs in appropriate system and collecting relevant metrics. *Collecting and tracking site intelligence and communicating such to appropriate stakeholders in the Study Team, Legal, Finance, etc. *Ensuring that CDAs and CSAs are off the critical path for study start up or study continued conduct where change orders are needed mid-study - meeting timeline commitments. Qualifications: *Appropriate tertiary qualification, health related (Medical, Scientific, Nursing) preferred. *Minimum three years clinical research experience including contract/budget negotiation. Proven negotiating skills, tact and diplomacy. *Understanding of medical and legal terminology and the application of business/financial concepts used in clinical research. *Extensive knowledge related to ICH/GCP Guidelines and applicable local regulations. *Ability to learn multiple concepts related to legal, compliance and regulatory matters in clinical research. *Ability to manage multiple priorities/projects. *Strong sense of urgency and ability to make decisions. *Good communication and interpersonal skills. Positive team player. *Good observational skills, analytical and conceptual capabilities. For further details about this role please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk

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