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.

Job Description

Purpose:

Describe the primary goals, objectives or functions 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, other site agreements and vendor agreements and issues on other legal, compliance, regulatory and policy matters (such as Insurance Policies, FMV, FCPA, etc.). With the minimum support from CMS manager and 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 of site contracts for Legal, Finance, Site Management & Monitoring and Study Team.
• Accountable for timely Preparation and Execution of CDAs, CSAs and Budgets, other site agreements 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 and other site agreements 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. Site visits may be conducted if necessary.
• Liaising with Legal where Playbook doesn’t already address an issue and seeking Legal approval for deviations.
• Setting, managing and communicating priorities on site level to local affiliate stakeholders, Legal, and Finance in alignment with Study Plans and priority for start up.
• Contribute site-level input to the continual update of Playbooks and Templates in collaboration with Legal.
• Tracking CDAs, CSAs and other agreements in appropriate system and collecting relevant metrics.
• Gathering, managing and tracking site intelligence and communicating such to appropriate stakeholders in the Study Team, Legal, Finance, etc.
• Ensuring that CDAs, CSAs and other agreements are off the critical path for study start up or study continued conduct where change orders are needed mid-study – meeting timeline commitments.

  Purpose:

  Describe the primary goals, objectives or functions 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, other site agreements and vendor agreements and issues on other legal, compliance, regulatory and policy matters (such as Insurance Policies, FMV, FCPA, etc.). With the minimum support from CMS manager and 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 of site contracts for Legal, Finance, Site Management & Monitoring and Study Team.
• Accountable for timely Preparation and Execution of CDAs, CSAs and Budgets, other site agreements 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 and other site agreements 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. Site visits may be conducted if necessary.
• Liaising with Legal where Playbook doesn’t already address an issue and seeking Legal approval for deviations.
• Setting, managing and communicating priorities on site level to local affiliate stakeholders, Legal, and Finance in alignment with Study Plans and priority for start up.
• Contribute site-level input to the continual update of Playbooks and Templates in collaboration with Legal.
• Tracking CDAs, CSAs and other agreements in appropriate system and collecting relevant metrics.
• Gathering, managing and tracking site intelligence and communicating such to appropriate stakeholders in the Study Team, Legal, Finance, etc.
• Ensuring that CDAs, CSAs and other agreements are off the critical path for study start up or study continued conduct where change orders are needed mid-study – meeting timeline commitments.

Qualifications

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).
• Demonstrates a proactive attitude, willingness to learn, and sound judgment in decision-making under guidance.
• Good communication and interpersonal skills. Positive team player. Good observational skills, analytical and conceptual capabilities.

Adaptable and flexible when facing changes in the work environment.________________________________________________________________________________

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