Specialist, Clinical Database Services Developer (Hybrid)

Job Description

Primary activities include, but are not limited to:

• Responsible for clinical database design and development activities supporting startup of a clinical trial.

• Activities supported may include standards technical component development and the design and implementation of the clinical study database.

• Reviews technical feasibility of proposed forms, edit checks, data reports and other database capabilities used for review, cleaning and verification activities of clinical data captured in clinical trials and technically implements them.

• Under proper change management, responsible for change requests and incidence correction into clinical database.

• Ongoing support in a dynamic and matrix organization. Works effectively among Clinical Database Services (CDS) staff to communicate issues and ideas to improve quality and efficiency.

• Participate in extra activities including, but not limited to, study improvement task forces, automations, initiatives, testing of new systems, and ongoing training and mentoring.

Minimum Education Required:

• Bachelor’s degree in computer science or equivalent professional experience to software design, procedure language, development theory and techniques, testing methodologies, and software documentation.

Qualifications, Skills & Experience

• A minimum of 2 years of database development and/or data cleaning programming experience, procedure language, development theory and techniques, testing methodologies, and software documentation

• Demonstrated strong technical proficiency in SQL or PL/SQL, C#.

• Preferably have other programming languages like Python, Java knowledge and experience.

• Desire and ability to learn new processes and technologies.

• Ability to multi-task, work independently, and good communication skills.

• Solid knowledge of MS Windows/Office software and exposure to web-based applications.

• Ability to establish and maintain good working relationships with different functional areas.

• Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.

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If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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