Senior Clinical Database Developer

Summary

Join MMS, an award-winning, data-focused CRO, and be part of a supportive, innovative team that values its employees. We offer a collaborative and inclusive work environment with an industry-leading customer satisfaction rating. As a Senior Clinical Database Developer (Rave), you will play a key role in shaping the future of clinical research. We support the pharmaceutical, biotech, and medical device industries. Our global presence spans four continents. We are recognized for our exceptional culture and industry-best employee retention rate.

Requirements

• At least 5 years’ experience with Clinical Database programming
• Strong management and Rave Study Build skills
• Expert Custom Function programming is mandatory
• College graduate in computer science or related discipline, or related experience
• Strong knowledge of drug development as it pertains to data management
• Hands-on experience with clinical trials and pharmaceutical development process
• Experience in pharmaceutical or CRO industry
• Knowledge of clinical database structures
• Knowledge of CDISC/CDASH data standards and their application to CRF and database design

Responsibilities

• Participates in protocol review with clients, provides suggestions regarding ability to capture protocol information in database successfully
• Contribute to study tracking and metric reports for use by the study team
• Contribute to CRF tracking and data entry, integration of external electronic data, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits
• Contribute to user acceptance testing (UAT) of EDC and integrated systems including executing of test plan and scripts
• Assist with preparation for training sites/users training on EDC applications, and UAT
• End user knowledge for study conduct activities including queries management, standard reporting and extracting data in multiple EDC systems
• Independently develops data entry screens, dynamics, edit checks and other EDC components in multiple EDC systems
• Ability to program using SQL, SAS or another programming language
• Provides input to resolve issues in data management study processing activities
• Develops appropriate study documentation
• Develops the clinical trial databases, data entry screens and edit checks
• Completes and oversees execution of user acceptance testing (UAT) of study-specific systems and applications
• Interacts with cross-functional team members to ensure completion of all timelines and studies
• Develops requirements and/or programs data listing and data edits as appropriate
• Assumes responsibility for quality and integrity of clinical database creation
• Trains sites/ users on EDC system and applications as appropriate
• Proposes and implements solutions to client issues where necessary
• Conducts thorough self-review of deliverables prior to release to client; serves as high level reviewer for others
• Ensures compliance to applicable ISMS policies and procedures
• Complies with Record Control Procedure