Clinical Data Programmer - Medidata Rave (4-8 yrs)
Job Description :
- This is a contract to Hire Role and can work from anywhere
- Custom function programming being the most important skill that we require.
- Contractors can sit anywhere in this country.
- 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.
- 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 end-user 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 set up 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 the 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 4 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 the 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.
Physical Requirements :
- 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.