Senior Contract Management Specialist (Clinical Research)
AbbVie
Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Joining AbbVie means, you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients' lives. At AbbVie, we conduct ground-breaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada.
When choosing your career path, choose to be remarkable.
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health, in addition to products and services across its Allergan Aesthetics portfolio.
The Senior Contract Management Specialist in Global Site Contracting / Clinical Development Operations may be responsible for ensuring the timely & appropriate execution of Clinical Study Agreements, Confidentiality Disclosure Agreements, Master Clinical Study Agreements, Investigator Initiated Study Agreements, Facility Use Agreements, other site related agreements, associated Budgets & service provider agreements linked to the individual CSAs. Works in partnership with R&D business teams/functional areas including Clinical Development Operations, Finance, Office of Ethics & Compliance, Legal, & external parties. Drafts, negotiations, & executes agreements & ensures final contracts are delivered to agreed timelines, within Fair Market Value & in compliance with relevant legal & regulatory requirements. The SSCM functions as an Americas contract management expert within the organization, & acts as an example & mentor for inexperienced colleagues, driving excellence & representing the group on functional improvement projects.
Responsibilities:
- Accountable for the timely preparation and execution of CSAs, CDAs, and budgets and associated vendor agreements. Americas, this role acts as point person for assigned country / region for legal, finance and CDO.
- Negotiation of CSAs, CDAs, other site agreements and Budgets with investigator sites (directly or with support where language necessitates), using appropriate templates, guidance, and legal/budget playbooks, liaising with R+D legal for approval to changes not already described.
- Provide input for ongoing update of applicable legal and budget playbooks and templates.
- Ensure appropriate tracking of CSAs, CDAs, Country and Site Intelligence, and the maintenance of necessary documentation per AbbVie requirements.
- Agree, manage, and communicate regarding priorities with CDO stakeholders, legal and finance, in alignment with Study and Priority planning. Effectively escalate / communicate to stakeholders and clinical teams in a diplomatic and timely way regarding contract issues that could impact project deliverables.
- Lead process improvement projects for the Americas Contract Management Function and/or be a SME representing the Americas Contract Management function on process teams with broader impact. Drive for excellence and continuous improvement in delivery of global Contract Management responsibilities.
- Demonstrates a high level of applicable competencies in contract management, critical thinking, highly competent in negotiation and contracting business standards.
- Provide guidance to team members within the Contract Management function. May triage and assign workload within the department and mentor/train junior staff members within the work team as requested.
- Partners with Country Operations Managers in the countries assigned line reports manage the contracts for, to ensure effective and efficient work processes. Ensure any issues are resolved.
Qualifications
- Bachelor’s degree or equivalent work experience; Health Care, business, legal, or scientific discipline preferred.
- Significant (at least 5 years) Clinical Research and/or contract/budget experience. Awareness and understanding of compliance and regulatory matters in clinical research. Experience in cross-functional interactions and working within a global environment an advantage.
- Proven negotiation, interpersonal and business skills.
- Strong planning and organizational skills and the ability to work independently and effectively in a dynamic environment with competing priorities.
- Sense of urgency and strong goal orientation; track-record of meeting deadlines and goals.
- Strong written and verbal communication including written and verbal fluency in English and local language (if not English) and interpersonal skills, including conflict resolution and problem solving.
- Proactive and positive team player. Able to maintain high performance during times of ambiguity and change in the work environment.
- Experience in line or matrix management an advantage.
- Experience in financial, budget, cost management/analysis, accounting, and/or financial planning skills are desirable.
Additional Information
This position can be remote from Canada.
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.
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