The Contract Management Specialist is 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.). In partnership with Legal they ensure that issues and points of negotiation are settled rapidly in support of our new model to minimize or eliminate negotiation and our aspirational target of first pass acceptance of these documents. The overall aim is to keep CDAs, Contracts and Budgets off the clinical study critical path for all our studies (both Site Management & Monitoring and CRO conducted studies). The responsibility is Global all countries except US, Puerto Rico and Japan.
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.
Good written and verbal communication skills. Written and verbal fluency in English and local language (if not English).
High degree of flexibility when facing changes in the work environment.
Serve as the point person for their country/region for Legal, Finance, Site Management & Monitoring and Study Team.
Accountable for the 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 (FMV) and actuals should be monitored.
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.
Input into legal aspects of the Informed Consents to ensure first pass acceptance or rapid resolution of issues using the Legal playbook/guidance or Legal consult if necessary.
Liaising with Legal where playbook doesnt already address an issue and seeking Legal approval for deviations.
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 the appropriate systems 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.