Purpose : Describes the primary goals,objective or function or outputs of this position. 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 AbbVie studies (both Site Management & Monitoring and CRO conducted studies). The responsibility is Global – all countries except US and Japan.
Responsibilities : List up to 10 main responsibilities for the job. Include information about the accountability and scope.
- 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. Liaising with Legal where Playbook doesn’t 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 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 : List required and preferred qualifications up to 10). Include education, skills and experience.
- 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 planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Ability to manage multiple priorities/projects.
- Good written and verbal communication skills. Written and verbal fluency in English and local language (if not English).
- Strong sense of urgency and ability to make decisions.
- Good communication and interpersonal skills. Positive team player. Good observational skills, analytical and conceptual capabilities.
- High degree of flexibility when facing changes in the work environment.
Job Type: Experienced