Job Description
The Sr. 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).
•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.
•Lead process improvement projects.
•Provide guidance to team members within the Contract Management function.•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.
•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 Spanish.
•Strong sense of urgency and ability to make decisions.
•Good communication and interpersonal skills. Positive team player. Good observational skills, analytical and conceptual capabilities.
•Able to maintain high performance during times of ambiguity and change in the work environment.
Mandatory hybrid model: Tuesday, Wednesday and Thursday onsite
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.