- Responsible for Designing CRF using leading EDC database systems
- Responsible for the preparation and /or review draft and final eCRF specifications, edit check specifications for assigned projects to ensure quality and consistency.
- Perform all activities related to specification development for study build and design of EDC databases according to standard procedures.
- Good organizational and time management skills with the ability to multi-task.
- Maintain awareness of new developments in EDC vendor products which may be applied to improve the efficient use of these systems.
- Responsible for performing quality control procedures for specification development.
- Participate in the validation of EDC studies when requested.
- Responsible for the creation and maintenance of library objects within the Global Libraries.
- Responsible for the management of standard objects within the Global Libraries.
- Complete work according to Labcorp drug development SOPs, Work Instructions, and project specific guidelines in accordance with Good Clinical Practice.
- Participate in the ongoing review of the processes to ensure adaptation of best practices.
- Prioritize personal workload to meet specified completion dates and perform work with minimal direction.
- Provide feedback to management if any action is needed to increase utilization, improve efficiency, or amend the resource levels required on a project.
- Provide expert guidance to project teams, external clients and internal clients within a global setting.
- Perform other duties as assigned.
- University/college degree (life science, computer science, pharmacy or related subject preferred) or equivalent experience.
- Certification in a related profession from an appropriately accredited institution (e.g., SAS certification, Programming languages / tools etc.). is an added advantage.
- Broad knowledge of drug development process.
- Thorough knowledge of leading EDC databases with regards to development of specifications.
- Working knowledge of eCRF Design.
- Working knowledge of CDISC and ICH-GCP
- Working knowledge of System Life Cycle in relationship to the implementation new applications.
- Fluent in English, both written and verbal.
- 0 - 2 years of relevant work experience to include data management and/or database programming/Designing activities.
- Demonstrate excellent problem-solving skills, a proactive approach and the ability to make sound decisions.
- Excellent oral and written communication and presentation skills.
- Knowledge of clinical trial process and data management, CRF/eCRF Design, CDISC.
- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
- Demonstrated ability to work in a team environment.
- Demonstrated ability to handle multiple competing priorities.
- Proven interpersonal skills.
Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed