Clinical Data Manager
Reports to: Head of Technical Service
Why you’re here
Responsibility for the design, implementation, conduct, reporting, closeout, and archiving of clinical trial projects conducted by GreenLight Clinical
What you’ll deliver
- Throughout the clinical program life cycle, provide data management leadership for assigned clinical projects and is responsible for the data quality, integrity, and accuracy.
- Maintain a high level of data quality by creating and adhering to standard eCRFs and data structures and corresponding standard edit checks and review listings, ensuring data from a variety of sources is collected and validated in a manner that ensures entirety and accurateness to meet the analysis needs.
- Oversees the design and conduct of EDC studies developed by external vendors with regard to GLC’s data collection and management standards
- Assist in the design and implementation of clinical data management processes with vendors, ensuring completeness, correctness, and consistency.
- Acts as the liaison between clinical, biostatistics, clinical safety, and clinical development teams and external vendors for data management matters on assigned projects.
How we’ll measure it
- Successful collaboration between functions within GreenLight Clinical for the projects you responsible for
- Effective and efficient implementation of clinical trial projects with defined KPIs: timelines, budget, profit margin, utilization, etc
What you’re responsible for
- Gathering requirements and preparation of specifications for database systems and integrations including but not limited to CDMS (clinical database management system), EDC (Electronic data capture) as InForm, Medidata Rave, Viedoc, OmniComm/Trial Master, Coding, Randomisation, ePRO, Supply management, CTMS, Safety systems, lab data uploads
- Scoping all development activities for database systems and integrations including study deployments and change orders
- Oversee project-specific database design and eCRF builds. Oversee the testing of data management system edit/validation checks and special listings/procedures used as tools for data review and discrepancy management activities. Responsible for the generation or review of Data Management Plans, Data Validation Plans and Quality Management plans to deliver accurate, timely, consistent quality data.
- Creation and development of edit check specifications, validation plans, quality reports, documentation of unit testing for all deployments and change orders to database systems.
- Programming edit checks in relevant systems e.g. Central Designer for deployment to EDC system and other systems (e.g. SAS)
- Supports improvement initiatives to enhance the efficiency and quality of the group’s deliverables.
- Unit Testing of rules and integration testing of complete EDC system
- Supports the development and maintenance of clinical data management operations and cross-functional Standard Operating Procedures and related QMS documents
- Contribute to library development of eCRFs and edit checks
- Assistance in supporting local information systems
- Independently, initiates, manages, and coordinates the activities of all external vendors that will process and transfer clinical data to GLC. Act as the primary point of contact for liaison with these vendors per study.
- Maintains up to date awareness of industry regulations and guidelines (GCP-ICH, 21 CFR Part 11, HIPPA
- Demonstrates strong time management skills including the ability to accurately scope and plan programming/technical activities
- Effectively communicate and mentor’s technical concepts to non-technical cross-functional team
- A Biomedical Science degree or equivalent combination of education, training, and relevant industry experience
- At least 6 years clinical data management experience, within the CRO/pharmaceutical environment. or bio/pharmaceutical setting, including interaction with Regulatory Agencies, especially FDA.
- Experience using Electronic Data Capture tool, Medidata Rave, and/or Viedoc preferred.
- Experience in writing and reviewing data management and data validation plans, as well as data management standard operating procedures is needed.
- Preferred therapeutic area experience: Ophthalmology, Oncology, Infectious diseases, Respiratory
- Advanced knowledge of programming language (e.g. C#, Java, C++)
- Advanced knowledge of SAS, SQL
- Knowledge of industry data standards (CDISC)
- Clinical Programming experience
Technical knowledge & skills or other requirements
- Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel
- Strong planning and organizational skills.
- Strong written and verbal communication skills
- Effective time management and organizational skills
- Attention to detail and accuracy in work
- Ability to work independently and ability to adapt to changing priorities
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Exhibits strong negotiation skills and can identify and engage internal and external expertise as needed
- Ability to collaborate effectively with the study team, cross-functional team members, and external partners.
- Results-driven with meticulous attention to detail
- Able to adapt to changing and competing priorities.
- Comfortable working in an entrepreneurial fast-paced small company environment.