Team Lead - EDC Development
Job details
Thursday, April 25, 2024 Job Summary : In collaboration with the Senior Director of Data Management and Bioinformatics, develops and maintains software and database systems ensuring compliance with specifications security, quality controls and trains company personnel on the use of the software. Essential Functions: The following duties represent the principal job duties however they are not all inclusive: Performs troubleshooting, bug tracking and evaluates software performance and proposes solutions Prepares user manual and instructions documents Provides software technical support Provides software reviews Ensures that the developed software adheres to company SOPs Works in compliance with project timelines Performs training Experience in documentation and validation of clinical trials software program Participates in the development and review of SOPs Acts as a substitute for the Database Administrator, if required Manages requests for the development of software, if required Reviews Software Data Some knowledge for data cleaning and database design Some knowledge as related to the submission of products for regulatory approval Additional Responsibilities: Knowledge of: Programming technology and advancements Requirements of Good Clinical Practices Requirements of Good Documentation Practices Requirements of 21 CFR Part 11 for Handling of Electronic Records Ability to: Maintain and exhibit discretion at all times when handling confidential information Plan work and carry through to completion Communicate effectively orally and in writing Assume multiple and concurrent tasks and responsibilities Establish and maintain cooperative and effective working relations with fellow employees Shift priorities as workload demands require Administering, maintaining, upgrading and trouble-shooting all company systems Demonstrate behaviors that are shared at JSS Medical Research: integrity, respect, professionalism, commitment, accountability Job Qualifications : General Knowledge, Skills, and Abilities (KSA's) required Experience and Education: University degree in Computer Science 2-4 years of relevant work experience Experience with object-oriented analysis and design Continuously using and applying technology to optimize processes We Offer: Short and Long Term Disability Life Insurance Dependent Care Flex Spending Account Voluntary Policies (Accident, Hospital Indemnity, Critical Illness & Supplemental STD) Genesis Global Group is an equal opportunity employer.
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