- 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.
- 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 Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.
Your new opportunity: We are seeking a commercial Senior Consultant to specialise in Risk and Compliance for our Finite office in Sydney. The Finite Group are one of Australia and New Zealand's most [...]
Your new opportunity: We are seeking a commercial Senior Consultant to specialise in Project Services for our Finite office in Sydney. The Finite Group are one of Australia and New Zealand's most awar [...]
Your new opportunity: We are seeking a commercial Senior Consultant to specialise in Risk and Compliance for our Finite office in Sydney. The Finite Group are one of Australia and New Zealand's most a [...]
Your new opportunity: We are seeking a commercial Senior Consultant for our Finite office in Sydney. The Finite Group are one of Australia and New Zealand's most awarded and trusted Technology and Pro [...]