Develop and maintain trial specific database applications, including eCRF's and database specifications, program validation and derivation procedures within the clinical database management (Medidata Rave) using relevant programming languages (C #) system in support of in-house and outsourced trials globally, of various levels of complexity for Phase I-IV independently or with minimal supervision.
Develop programming/configuration of Rave CRFs, folders, edit checks, derivations, integrations, migrations, and reports.
Analyze and comprehend Rave Custom Functions (CFs). Expertise in writing and debugging Rave CFs is highly preferred.
Oversee the administration of Rave modules such as Reports Administration, TSDV, PDF Services, Batch Uploader, User Administration, eSAE (Safety Gateway), and Site Administration.
Offers both technical and user support.
As directed by the manager, builds and validates Rave studies.
Collaborates on Rave projects with other IT employees.
Successfully collaborates with vendor partners throughout testing and deployment.
Follows all GCP (Good Clinical Practice) regulations and the Software Development Life Cycle (SDLC) SOPs for the development and validation of the database development
Properly manages their time. Meets deadlines and accurately estimates work for tasks. Adapts to regularly shifting demands, priorities, and time constraints.
Promptly investigates and fixes technological problems.
Actively shares information on build efforts with the management team and clinical teams.
Best level of written and verbal communication abilities.
Before emailing written communications, proofread them thoroughly.
Capable of taking part in video conferences.
Speaking with assurance in all situations.
At least 6 years experience in clinical database programming, setup of clinical databases and CRF design, and procedure /validation programming, as part of the setup of clinical databases, gained in the pharmaceutical industry, CRO or Life science related industry as well as the following:
Strong Clinical Data Management and Medidata Rave Study Build skills.
The ability to program in C# is preferred.
It would be advantageous to comprehend the Medidata Rave Object Model.
Excellent interpersonal skills.
Demonstrate capacity to multitask and work in a fast-paced workplace.
Effective communication skills
Strong problem-solving and analytical abilities.
Strong focus on providing high-quality results while paying close attention to the details.
Highly effective capacity to foresee project-related issues and to create and carry out solutions.
Outstanding interpersonal abilities.
English proficiency in both writing and speaking.
Extremely well-organized and goal-oriented.
Advanced Excel and Word skills.
