Job Description
Primary activities:
•Assumes the responsibilities for all clinical programming (including reporting and analytics) deliverables including Oracle, Veeva platforms along with the external data captured in support of the clinical studies.
Coordinates and participates in the following activities:
•Design, build, maintain, test, and document data review based on written specifications established by Global Clinical Data Management, Clinical Research and Global Safety. Review the technical feasibility of study team proposed programming/reporting and technically implements them. Work effectively among team to communicate issues and ideas to improve the business along with understanding of Protocol.
•Support the development & reporting for data cleaning, medical review, clinical monitoring, and safety reports for quality and timely availability in support of our customer needs.
•Perform ongoing support for In-Life Reports. Change Requests and Incident Reports are fully documented, signed off, tracked, and reported to upper management.
•Participate in extra activities including, but not limited to, study improvement task forces, automations, initiatives, testing of new systems, and ongoing training and mentoring.
Qualifications, Skills & Experience:
Education:
•B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant Pharma skills and experience.
Knowledge and Skills:
•Expected to have a good technical proficiency in a Clinical Data Management/Reporting Systems like PowerBI or SQL/PL SQL or Databricks or Python or SAS, etc. along with AI related tools.
•Solid knowledge of MS Windows/Office software and exposure to web-based applications.
•Solid knowledge of System Development Lifecycle Management / system validation knowledge
•Ability to establish and maintain good working relationships with different functional areas.
•Strong sense of urgency and customer focus.
•Possesses excellent communication skills and interacts effectively with Study Team along with Strong organizational and problem-solving skills.
•Desire and ability to learn new processes and technologies.
•Ability to multi-task, work independently, and good communication skills.
•Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH.
•Must currently hold a B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science OR receive a B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science no later than spring 2027.
Required Skills:
Clinical Data Management, Clinical Programs, Clinical Research, Data Entry, Data Management, Data Processing, Data Reporting, Data Review, Good Clinical Practice (GCP), Protocol Management
Location: USA - New Jersey - Rahway
Salary range for the primary location: $71,900.00 - $113,200.00. This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days.
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Hybrid
Shift: 1st - Day
Valid Driving License: Yes
Hazardous Material(s): No
