Manager, Clinical Programming
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.
Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.
What Your New Manager Wants You To Know
AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.
YOU ARE more than just a title, YOU ARE…
First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.
- Actively participate in the development of common data standards and ensures systems designs comply with the standards, as well as with associated protocol requirements.
- Establish and maintain methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards. Ensure that systems are specified to optimize on functionality, end user experience, and data flow. Ensure that the design team meets these expectations
- Ensure that TA- and program-level consistency is achieved by the design team
- Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well any required changes to clinical systems (e.g., EDC-RAVE). Utilize project management tools to track study progress and plan work. Anticipate and identify issues that could affect timelines or quality and develops options and solutions
- Interact with and influences DSS and cross-functional team members to achieve program and study objectives. Ensure that assigned work product is synchronized with upstream and downstream dependencies
- Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stay abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
- Be responsible for coaching and mentoring members of the team, as well as contributes to their skill development
- Lead DSS and cross-functional innovation and process improvement initiatives
- Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred.
- Must have 5+ years of clinical technology experience (e.g. EDC – RAVE) or 7+ years of experience in a similar technical role or in a clinical development role.
- Experience with common industry design and development tools required.
- In-depth knowledge of clinical trial process.
- In-depth knowledge of CDASH and SDTM.
- Demonstrated performance as a key contributor to initiatives and advancement of the organization.
- Demonstrated ability to influence others without direct authority.
- Demonstrated ability to successfully coach / mentor in a matrixed environment.
- Demonstrated effective communication skills and analytical skills.
In this role, we’re looking for a leader who will:
· Act as an Owner
· Be Excellence Focused
· Act as an Influencer
Significant Work Activities
Yes, 5 % 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.