Clinical Data Systems Lead (Onsite or Remote)
Clinical Data Systems Lead (Onsite or Remote)
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1 Vacancy
Job Description
AbbVie Clinical Data Strategy and Operations is the bestinclass team within its crossindustry 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 studylevel 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 decisionmaking 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
The preferred location for this role is AbbVies Lake County Illinois office on a hybrid onsite schedule; however we are open to candidates working remotely within the United States.
Qualifications :
- Bachelors degree in business management information systems computer science life sciences engineering or equivalent. Masters 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 problemsolving 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 shortterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
