Title: Medidata Rave Programmer
Must have :
Custom function programming experience and Medidata Rave experience
At this time, we have two teams hiring for CDMP- RAVE contractors. Oncology experience is not required. We plan to use these resources for a variety of therapeutic areas (although the bulk will probably be oncology). Contractors can sit anywhere- no specific west/east coast requirement. The contractor will be expected to hit the ground running taking PPD SOP's and building out the study. Must have experience with programming edit checks and custom function programming. **Custom function programming being the most important skill that we require.
Database position working with clinical trials data systems under general supervision. Provides technical leadership for some or all of the following activities:
- Designs and implements global library and study specific setup for clinical trials applications; develops and validates data checks; provides first-line enduser support/problem solving; provides support for application validation activities.
- Serves as Technical Lead on Study specific database design / build activities adhering to the timelines established by the project team and indicated by the contract.
- Reviews designs for compliance/feasibility within the database system and consistency with any current standards and/or sponsor specification and meets with study teams on a regular basis during initial study setup to ensure effective communication and accuracy in design
- Develops and validates data checks and performs core setup and supports processes for various peripheral systems
- Coordinates the activities of other Database Programmers that might assist in building studies to ensure all jobs are carried out and timelines are met.
- Updates annotations and production databases where required based on protocol amendments or other changes to trial designs within timelines as agreed with project team
- Provides basic technical support / consultancy and end-user support
- Works with IT in troubleshooting, reporting and resolving system issues
Minimum Required Education and Experience:
- Bachelor s degree in computer science, statistics, biostatistics, mathematics, biology or other health related field or equivalent experience that provides the skills and knowledge necessary to perform the job.
- Minimum of 2 years experience in a clinical trials environment or similar field
- Minimum of 1 years experience with Oracle or similar applications in a programming or administration capacity. OC/RDC experience preferred.
- Minimum of 1 year experience with Medidata Rave and/or Rave certification
Required Knowledge, Skills and Abilities:
Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
Good computer skills:-
- Knowledge of relational database systems (RDBMS) and structure
- Experience in Oracle and with Oracle tools or similar, with working knowledge of SQL and/or PLSQL
- Strong attention to detail and problem solving skills
- Good written and verbal communication skills
- Demonstrated experience in identification and resolution of technical problems in a professional environment
- Ability to maintain a high degree of confidentiality with clinical data and client s proprietary data
- Ability to attain, maintain and apply a working knowledge of GCPs and applicable SOPs
- Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others.
Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.
- Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.