Data Management Systems Specialist (Contractor)

Job Title: Data Management Systems Specialist (Contractor)

Job Number: 84845

Location: Remote, US

Job Description

The Clinical Data Management Systems Specialist Contractor provides expertise in clinical database configuration, site management, and user access for project teams. The ideal candidate should have strong knowledge of clinical data management systems and relevant global regulatory standards (e.g., ICH, GCP). This role involves supporting database components of projects, including modules for coding, randomization, and trial supply management. The individual may also contribute to department initiatives and other non-study projects.

Responsibilities

* Serve as system administrator, managing user access for various platforms (EDC, coding, lab administration, imaging). * Support core system configurations and collaborate with internal and external teams to implement best practices. * Maintain proper documentation of system maintenance tasks and updates. * Provide technical support for site and user access within RAVE modules. * Escalate issues to appropriate support teams as needed. * Configure RAVE user roles and make updates as necessary. * Assist with lab administration configuration as required. * Program forms, edit checks, and custom functions in line with data collection standards. * Attend meetings with internal teams and vendors to discuss system maintenance and updates. * Participate in relevant training sessions to support job functions. * Contribute to departmental initiatives (e.g., SOPs, guidelines, templates). * Maintain internal data management files, ensuring regulatory inspection readiness. * Perform other duties as assigned.

Required Skills

* Bachelor’s degree with 2 years of experience in Clinical Data Management or 4 years of equivalent experience in a related role * Knowledge of ICH, FDA, and GCP regulations and guidelines * Proven ability to deliver high-quality data management outputs within deadlines * Highly organized, results-driven, and self-motivated * Adaptable to changes in a fast-paced environment * Experience with EDC systems, preferably with full development lifecycle exposure (familiarity with platforms such as Rave EDC, RTSM, Safety Gateway, Imaging, Coder, Lab Management, and basic configuration is a plus) * Understanding of industry standards such as CDISC/CDASH * Familiarity with MedDRA and WHO Drug data dictionaries * Experience with external data integrations into EDC systems * Skilled in ad hoc reporting, data review listings, and metrics reporting * Strong attention to detail and ability to work independently in a cross-functional team and with external partners * Strong verbal and written communication skills, with a focus on positive collaboration * Ability to explain technical data management concepts to other teams and provide updates within the department * Capable of training and mentoring other team members * Oncology experience is a plus

Application Deadline: 2024-11-04