Specialist, Clinical Database Services Developer (Hybrid)
USA - New Jersey - Rahway
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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NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, …
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Hybrid Hybrid work model Vaccination requirement for external stakeholder interactions
Benefits/PerksFlexible work arrangements Hybrid work Hybrid work model Insurance Meetings Paid holidays Retirement benefits Sick Days Vacation
Tasks- Change Management
- Collaboration
- Communication
- Development activities
- Innovation
- Mentoring
Business Operations C Change Management Clinical Clinical trials Collaboration Commercial Communication Computer Science Data Database design Database Development Data Cleaning Design Drug Discovery FDA regulations GxP Guidelines ICH ICH Guidelines Innovation Java Management Manufacturing Matrix organization Mentoring MS Office PL/SQL Programming Python Quality Research Software design SQL Technical Testing methodologies Training Web-based applications
Experience2 years
EducationBachelor's degree Business Computer Science Management MS Science
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9