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Principal EDC Lead – EDC Standards (On-Site) Fulltime
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 Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
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.
Responsibilities
Drive the Overall eCRF Library Development and Maintenance Project. Proactively Identify, Manage and Deliver Individual Components of Library working with various stake holders.
Develop Process and Tools to Ensure Consistency in Process, Implementation and Quality of CDASH and Abbvie Data Collection Standards.
• Actively participates in the development of common data standards and ensures EDC systems designs comply with the standards, as well as with associated protocol requirements. Ensures that the design team utilizes standards.
• Establishes and maintains methodology used by the team to design and develop EDC systems, benchmarking against industry standards. Ensures that systems are specified to optimize functionality, end user experience, and data flow. Ensures that the design team meets these expectations.
• Ensures 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 EDC systems. Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions.
• Interacts with and influences DSS and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies.
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development.
• Responsible for coaching and mentoring members of the team, as well as contributes to their skill development
• Leads DSS and cross-functional innovation and process improvement initiatives
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications
• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred.
• Proven expertise in specialized standards development skills, with an emphasis on raw data standards. Excellent knowledge of industry standards such as CDASH, SDTM and a knack for problem-solving with these tools
• Strong project management capabilities and experience mentoring, training, and leading teams.
• Must have 5+ years of EDC clinical technology experience. Experience with Veeva CDMS Studio preferred.
• 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.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie 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.
