Company DescriptionAbbVie'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 DescriptionAbbVie Clinical Data Strategy and Operations is the best-in-class team within its cross-industry peer group. We are 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 a key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences. Responsibilities:
Develop a deep understanding of the capabilities and data flow for clinical technologies
Support the delivery of clinical technologies for a given program or therapeutic area
Track and analyze system timelines and metrics to ensure adherence to project plans, identify and mitigate potential risks and assess performance
Develop actionable reports and presentations for stakeholders and senior leadership to inform decision-making and project adjustments
Collaborate with internal and external stakeholders, including system leads, data management team, clinical teams and vendors
Contribute the strategic development of clinical technology initiatives and lead the implementation as the tech project manager
Maintain technical knowledge of the clinical data systems (EDC, IRT, eCOA, CDR and Imaging) and understand how the capability contributes to the submission data flow and overall DSS technology strategy
Mentor Clinical Data Strategy and Operations Associates
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
Act as the clinical data systems SME during regulatory inspections and internal quality audits
Qualifications
Bachelor’s degree in business, management information systems, computer science, life sciences, engineering or equivalent. Master’s preferred.
4+ years of pharmaceutical, clinical research, data management, health care technology experience or 6+ years of broader technology experience.
Familiar with clinical trial process and clinical technology.
Demonstrated knowledge of SAS and/or SQL programming skills and knowledge of database concepts.
Familiar with CDASH and SDTM Standards.
Demonstrated leadership traits and ability to influence without authority.
Demonstrated effective communication skills.
Demonstrated effective problem-solving and analytical skills.
Additional InformationApplicable 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.
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 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 US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:https://www.abbvie.com/join-us/reasonable-accommodations.htmlSalary: $80,500 - $153,000
