The Clinical Systems Coordinator is responsible for the overall coordination and management of the set-up, implementation, design and maintenance, development and security of various clinical information systems including but not limited to Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and electronic Data Capture (EDC) systems, Electronic Health Record (EHR) among others.
- In collaboration with the management, determines overall strategy in building and shaping the clinical systems and IT structure within the company.
- Develops, maintains, and oversees applicable SOPs and templates to ensure that routine clinical systems operations are performed in adherence with ICH/GCP/regulatory guidelines and established best practices in collaboration with the Quality manager.
- Advises on policies and latest trends on clinical systems and information security across the organization.
- Manages projects to ensure effective integration of clinical systems as appropriate.
- Leads in searching and selection of suitable system vendors.
- Guides the team in the development and design of a compliant GxP in-house clinical system applications and tools and ensures validation of these tools.
- Leads process improvement initiatives to streamline and standardize system processes.
- Leads user training (internal and external) and train-the-trainer training sessions, establishing, and maintaining user reference materials for all user types.
- Delegates task appropriately and coaches the team as needed.
- Liaise with different system vendors for system updates and technical inquiries.
- May participate in activities related to building study databases and applies advanced knowledge in the programming of complex CRF design, database building, edit checks, intermediate to complicated reports, custom programming, system interfaces and all system feature configurations.
- May provide guidance /advice to customers on the selection, implementation, and management of clinical systems in accordance with the SOW.
- May act as an administrator in the applicable clinical systems.
Skills and Qualifications:
- Bachelor or master’s in computer science, software or application development or other IT related courses.
- Proven experience in software and application development.
- Working knowledge of clinical trial operations and/or clinical data management
- Strong background of 21 CFR part 11 and GAMP5 is desirable
- With good communication and interpersonal skills.
- Familiarity with project management
- Agile and with Can-Do attitude.
- Affinity with lean principles
- Passionate about technology and always go the extra mile to get the most suitable technological solution
- Strong leadership and coaching skills
Bachelor’s degree, in health care or other scientific discipline or educational equivalent or equivalent combination of education, training and experience.
If you are interested, please send us your CV and motivation and get in touch with us at firstname.lastname@example.org