Specialist, Contract Management Pharmaceutical Development

BioSpace; Sofia (NM); On-site; USD 95,000 - 135,000; Full time

Job summary

AbbVie is seeking a Contract Management Specialist to oversee CDAs, CSAs, and budgets globally (excluding US, Puerto Rico and Japan). You will negotiate with investigator sites, manage timelines, and coordinate with Legal, Finance and Site Management to keep contracts off the critical path for study start-up.

Requirements include a health-related degree and 3+ years in clinical research with strong negotiation, regulatory, and language skills.

Qualifications

• Health-related degree preferred (Medical, Scientific, Nursing).
• 3+ years clinical research experience including contract negotiation.
• Understanding of medical and legal terminology in clinical research.
• ICH/GCP knowledge and local regulatory familiarity.
• Ability to learn legal/compliance concepts in clinical research.

Responsibilities

• Serve as the point person for country/region for Legal, Finance, Site Management & Monitoring and Study Team.
• Ensure timely preparation and execution of CDAs, CSAs and Budgets.
• Direct negotiation of CDAs, CSAs and Budgets with sites using templates and Legal guidance.
• Input into legal aspects of Informed Consents to ensure rapid resolution.
• Liaise with Legal for deviations and approvals.
• Set priorities with local affiliates, Legal, and Finance in alignment with study plans.
• Provide input into updating playbooks and templates with Legal.
• Track CDAs and CSAs in the appropriate systems and collect metrics.
• Communicate site intelligence to stakeholders in Study Team, Legal, Finance, etc.
• Ensure CDAs and CSAs are off the critical path for start-up or conduct.

Skills

Contract negotiation

Clinical research

Budget management

Regulatory knowledge

English fluency

Education

Clinical research degree

Health-related qualification

Job description

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
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, Puerto Rico and Japan.

Responsibilities

• 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. 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 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 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 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.

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 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.

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