Manager I, SMA
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 and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Location: This role may sit out of AbbVie HQ (North Chicago) or AbbVie Affiliate office-based or full-time remote/home-based depending on business need.
SMA Manager I, Study Management, reports into the Clinical Study Leadership (CSL) Global Lead and is responsible for managing a cohesive team of front-line study execution staff to deliver best-in-class study execution. They ensure clinical research studies are executed on-time with quality and efficiency, ensure that the strategies and tools selected are implemented appropriately, and ensure best practices are maximized to drive execution. They are responsible for managing processes/programs in multiple countries and across multiple Therapeutic Areas.
•Delivering on best-in-class study execution, while driving financial/headcount efficiencies, and increasing flexibility to rapidly respond to shifting business needs.
•Partnering with study teams to drive the implementation of the aggressive execution strategies.
•Resourcing, development of high performing teams, contracting, budgeting, hiring, performance reviews, and leading talent development of staff, including: linking the “why” and bigger picture, elevating team to think more strategically, creating a culture to drive efficiencies and innovation, and creating an inclusive and supportive environment in which staff are empowered to achieve peak performance.
•Utilizes strength in study execution to support front-line staff and strength in influencing/partnering to build trust with CDO and cross-functional stakeholders.
•Key contributor to process improvement, best practice sharing, and lessons learned. Primary contributor to training and development of SOPs, job aids, tools, templates, and work instructions in partnership with CSL leadership.
•Contributing to study execution intelligence gathering across multiple countries and TAs and maintaining performance metrics and KPIs.
•Ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
•Bachelor's Degree required, degree in health care or scientific field preferred.
•Minimum of 6 years of clinical research experience, with 4+ years of relevant study operations management and people management/mentoring experience.
•Proven leadership skills in a cross-functional global team environment, experience in managing remote/virtual teams, and an ability to influence and align stakeholders, while modeling and driving AbbVie’s leadership attributes.
•Successful coaching/mentoring, directly or in a matrix environment.
•Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making. Excellent interpersonal skills with the ability to build trust and communicate persuasively and with clarity, flexibility, and adaptability to changing requirements, and building strong relationships with cross-functional partners while respectfully challenging team members.
•Expertise in drug development, operations, risk management, successful decision-making, strategic execution, across global geographies and/or multiple therapeutic areas, in a fast-paced environment.
•Demonstration of successful study execution and aptitude for managing multiple priorities in a fast‐paced environment.
•Advanced working knowledge of ICH and GCP guidelines and operational understanding of the global regulatory environment.
•Considered a subject matter expert in the application of Standard Business Procedures (International Conference on Harmonization, Global Regulations, Ethics and Compliance).
CSL TA Heads, ASLs, TA MDs, CSL PLs, CSL SPMs, GSMLs, etc.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 10 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.