Clin Apps Programmer II

Job Location(s) CN-Shanghai
Job Number
Job Category
Clinical Data Management
Position Type

Job Overview

- Expected to assist with leading EDC Builds and mentor the study team in setting up Medidata RAVE, Oracle Inform, or SAS or any other proprietary software.
- Oversees the project work of technical and design staff.
- Manage projects within the scope of assigned budgets.
- Notify project leadership of requests for out-of-scope work and advise management of changes in scope of projects to enable the timely development of change orders.
- Mentor and aide in staff development, and achievement of competency standards
- Assist in the development and implementation of solutions to global technical service issues and concerns regarding Medidata RAVE, and Oracle Inform, or SAS or any other proprietary software, including proactive prevention strategies
- Assist in development of global technical services competency models
- Assist with the development of training programs to ensure staff, project and technical, achievement of position competencies. Present training programs to the technical staff regarding study build, change control and/or CRF Design or SAS reports, listings, Reconciliation reports.
- Participate in the development of global, harmonized SOPs and specific quality work instruction for technical service group activities
- Provide support and trouble-shooting of EDC/SAS and act as the study team liaison.
- Complete assigned work utilizing Medidata RAVE or Oracle InForm or SAS or any other proprietary software according to Covance SOPs, Work Instructions ,and project specific guidelines in accordance with Good Clinical Practices
- Set up EDC DB, program derivations, edit checks, custom functions, SAS checks, listings, reconciliation reports and any post production changes either in EDC or SAS as per business requirements.
- With assistance meet with data manager on assigned projects to discuss technical strategies, contractual obligations and timelines. Escalate resource needs as appropriate.
- Provide consultation in the area of database design and development with data managers.
- Participate in the ongoing review of the processes used by the Acquisition Configuration Implementation and Standards Group to ensure adaptation of best practices.
- Prioritize personal workload to meet specified completion dates and perform work without direction.
- Conduct Peer Review/ Quality Control of study design for assigned projects.
- Review and approve derivation and edit checks requested by the project teams. Discuss alternative programming for procedures, if appropriate.
- Program, test, and maintain derivation and edit check procedures in the EDC environments or SAS programming.
- For EDC systems/SAS, program integrated and associated components as assigned.
- Assist in developing and maintaining data loading procedures.
- Provide feedback to management if any action is needed to increase utilization, improve efficiency or amend the resource levels required on a project.
- Participate in the evaluation and validation of new or updates to software.
- Assume leadership on EDC, SAS sub-team committees. Participate/Lead local User Groups.
- Provide expert technical guidance to project teams, external clients and internal clients within a global setting.
- Prepare and provide internal training on advanced topics as needed in conjunction with senior management.
- Implement processes as they are refined or as new processes are developed and initiate and participate in the ongoing review of the processes to ensure they are continually improved.
- Provide feedback to management on the development potential of staff to assist in staff development.
- Maintain awareness of new developments in EDC or SAS products which may be applied to improve the efficient use of these systems.
- Perform all work with knowledge of regulations pertaining to computerized systems to projects to ensure compliance.
- Perform other duties as assigned.


- University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology)
- Broad knowledge of drug development process
- Basic knowledge of budgets and relationship to productivity targets
- Thorough knowledge of Medidata RAVE, Oracle Inform, SAS
- Working knowledge of CRF Design and SAS programming.
- Working knowledge of System Life Cycle in relationship to the implementation new applications
- Fluent in English, both written and verbal


- 6 - 8 years of relevant work experience to include data management and database support: EDC systems programming or SAS programming.
- Demonstrate excellent problem solving skills, a proactive approach and the ability to make sound decisions.
- Demonstrated skill in leading teams, by example and mentoring staff
- Excellent oral and written communication and presentation skills
- Knowledge of clinical trial process and data management, CRF Design, SAS programming and systems applications to support operations
- 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 managerial and interpersonal skills.


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