Study Management Associate

**General Position Summary/Purpose**

The SMA Manager II is the higher level of two roles in the SMA Manager job family, reports into the Clinical Study Leadership (CSL) SMA Associate Director 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.

**Key Accountabilities/Core Job Responsibilities**
- 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 in challenging spaces such as Enterprise Critical programs (where the criticality of delivery requires proactive planning for execution on deliverables, development and deployment of key talent, seamless responsiveness to work volume increases, immediate replacement/backfilling of support with exact skillset match), filings (where enhanced behavior coaching is required for interactions with auditors, etc.
- 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 of challenging the status quo to drive efficiencies and innovation, bringing ideas from outside of AbbVie, inspiring the team, and creating an inclusive and supportive environment in which staff are empowered to achieve peak performance.
- Utilizes deep understanding of study execution to support front-line staff and strength in influencing/partnering to build trust with CDO and cross-functional stakeholders.
- Coach and mentor junior and peer SMA Managers, as well as advise those mangers on actual challenges they’re facing. Establish and conduct managerial learning forums junior and peer SMA Managers (i.e., Managing and Coaching Poor Performer’s Forum).
- Develop SMA IIIs to be strong peer coaches, through individual coaching and through establishment and conduct of coaching learning forums.
- Analyze internal and external market intelligence to identify and drive process improvement and innovation.
- Design and create training curriculum as well as lead development of SOPs, job aids, tools, templates, and work instructions in partnership with CSL leadership that drives consistency, alignment, and efficiencies across multiple Therapeutic Area study execution.
- Contributing to study execution intelligence gathering across multiple countries and TAs. Analyze performance metrics and KPIs to identify trends/risks and develop mitigations.
- Ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
- Lead cross functional initiatives and initiatives within the Study Management organization.

**Education/Qualifications**
- Bachelor's Degree required, degree in health care or scientific field preferred.
- Minimum of 8 years of clinical research experience, with 6+ years of relevant study operations management and people management 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 and 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, and resource/budget planning across global geographies and 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.