Clinical Database Associate
PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.
JOB RESPONSIBILITIES:
- Users and Sites Administration in Medidata Rave and/or other software used by the data management and clinical teams. For Medidata platform this includes CTMS, eTMF, MMI, Coder, RTSM, and other modules, as needed.
- Learn current approach and suggest process improvements; define new ways to create efficiencies
- Take ownership of the process
- Create instructional documents and “cheat sheets” for other users to follow
- Assist with Lab Administration and the upload of local lab files
- Quality check database structures to ensure they are in accordance with the eCRF specification
- Assist lead programmer with the development of forms in Medidata Rave according to the eCRF specification
- Assist lead programmer with the development of edit checks in Medidata Rave according to the data validation specification (DVS)
- Participate in unit testing of custom functions, forms and edit checks
- Using SAS, B04 or JReview generate status and metric reports to support the data managers
- Perform other duties as required
TRAINING/LEARNING:
- Work within the Data Management / Database Programming department to receive training including but not limited to:
- Introduction to clinical trials/drug development process
- Introduction to principals of database programming and data management for clinical trials
- Medidata Rave training with a focus on learning what is needed for granting access
- Subsequent full set of trainings on the Medidata platform including but not limited to e-CRF design
- Training in SAS as applicable to data management
EDUCATION/EXPERIENCE:
- Educational background and/or previous experience in a computer science, applied math or information systems related field is preferred
- Educational background and/or previous experience in a scientific or health related field is preferred
SKILLS:
- Knowledge of and experienced in using Excel
- Focused attention to detail is critical
- Highly motivated self-starter, not afraid to take control
- Strong verbal and written communication skills
- Comfortable using computer programs and systems
- Open to learning and development
- Knowledge of programming language such as Python, R or SAS is preferred
PHYSICAL REQUIREMENTS:
Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.