Associate, Study Management III

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 Twitter, Facebook, Instagram, YouTube and LinkedIn. 

• Supporting the Study Project Manager in strategic leadership of the cross-functional team through stakeholder engagement and influence to drive deliverables and timelines including study-level oversight and leadership of assigned activities within one or more global trials in a cross-functional environment for activities from inception through closure. 

• Vendor management, from initiation through closure, including deliverable oversight, and risk management for one or more vendors. 

• Recruitment management, from country feasibility through subject recruitment and retention. 

• Leadership of assigned meetings and training (internal and external) and provision of regular updates on study status, e.g., agenda and minutes.  

• Ensure inspection readiness and participate in related activities. 

• Risk identification, mitigation, and management. 

• Co-development and management of study materials and systems throughout study life cycle (e.g., Protocols, informed consent, clinical study report, training materials, newsletters, presentations, IP, CTMS, eTMF, EDC, IRT, ePRO, access management, etc.)  

• Provide engaging training to identified stakeholders as needed. 

• Support process improvement initiatives. 

• Bachelor’s Degree or OUS equivalent required 

• Must have at least 4 years of progressive Pharma-related/clinical research-related experience with a high level of core and technical competencies 

• Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations) 

• Experienced user of systems such as EDC, IRT, CTMS, and eTMF 

• Strong analytical and critical thinking skills to evaluate complex issues to support smart decision making and enable a well-run study  

• Excellent organizational and time management skills, strong attention to detail 

• Exceptional interpersonal skills with ability to communicate effectively in a clear and persuasive manner in a global setting; proficient in business/technical English-language (oral and written)  

• Proactive, collaborative mindset 

• Ability to work independently in a fast-paced global team environment  

• Preferred: Exposure to study initiation through completion activities; global study exposure 

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

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