Copy of Senior Analyst, Clinical Data Systems
Copy of Senior Analyst, Clinical Data Systems
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1 Vacancy
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
- Ensure that clinical systems are designed in alignment with the specifications of each study protocol while promoting the use of common data standards across studies.
- Ensure systems are specified to maximize functionality enhance the end-user experience and support efficient data flow.
- Responsible for the timely testing and delivery of clinical trial systemsacross platforms such as IRT EDC and eCOA. This includes leading user acceptance testing (UAT) and validation activities to ensure system functionality aligns with protocol requirements and user needs. Utilizes project management tools to track study milestones plan execution and proactively address risks to timelines or quality through practical data-driven solutions.
- Ensure therapeutic area (TA) and program-level consistency across clinical systems.
- 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
- Ensure compliance with federal and applicable local regulations Good Clinical Practices (GCPs) ICH Guidelines AbbVie Standard Operating Procedures (SOPs) and established functional quality standards. Maintain up-to-date knowledge of emerging or updated local regulations guidelines and policies relevant to clinical development.
- Responsible for coaching and mentoring Data Science Associates
- Participates in DSS and cross-functional innovation quality and process improvement initiatives
Qualifications :
- Bachelors degree in business management information systems computer science life sciences or equivalent. Masters preferred
- 4 years of experience in clinical technologies (e.g. IRT EDC eCOA) or in a quality-focused role; or 6 years of experience in a comparable technical quality clinical development or programming position.
- Demonstrated SQL and PL/SQL skills
- Demonstrated understanding of CDASH & SDTM
- Demonstrated understanding of clinical trial applications and clinical development process
- Demonstrated leadership traits and ability to influence without authority
- Demonstrated effective analytical skills
- Demonstrated effective communication 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.
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 :
Full-time
Employment Type
Full-time
