Clinical Database Analyst III
About the position A Clinical Database Analyst III is responsible for ensuring the quality and integrity of clinical data via the creation of tools such as data collection instruments, data management plans, database specifications, and checks the review of clinical data for completeness, accuracy, and consistency. This is achieved through collaboration with clinical colleagues (e.g., Project Management, Trial Operations, Site Operations, Clinical IT, Global Safety, Biostatistics, Quality and Medical Sciences) and other cross-functional team members (e.g., Legal and Regulatory). You will primarily be focused on electronic Case Reports Forms (eCRFs) design, configuration, and validation. This is the role in charge of the creation and the updates of the associated clinical database where the study data will be captured, reviewed, and stored. This is a hybrid position (in the office minimum for three days per week) with the flexibility to be located in Minnesota or Massachusetts. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist. Responsibilities • Maintain and communicate high-level project planning based on the clinical study timelines and the priorities defined by management. • Review clinical protocols, identify data requirements and provide feedback to the owner in order to streamline data capture. • Collaborate actively with the study team to clarify study-specific needs. Provide subject matter expertise to project team members during all phases of project life cycle. • Create or update the study-specific eCRFs in the approved data capture system (Medidata Rave), including complex edit checks to verify the data completeness, accuracy and consistency in accordance with the investigational plan. • Ensure complete peer review of the technical design including forms, fields, matrices, edit checks and derivations. • Leverage standard forms, design patterns and naming conventions to guarantee consistency across studies. • Define and execute data entry scenarios or test scripts to ensure a complete and comprehensive validation of the eCRFs. • Identify payment rules based on study budget in collaboration with the Payment Specialist and the Clinical Trial Manager. Configure the associated compensation forms implementing all the required triggers. • Collaborate with technology teams to ensure the required systems and reports are developed and released on time to meet the study requirements. • Organize and facilitate regular interactive review meetings with the study team and formal User Acceptance Testing. • Follows functional documentation and guidelines and work in accordance with Good Clinical Practices (GCP) and Good Documentation Practices (GDP). Requirements • Minimum Bachelor's degree or appropriate equivalent • Minimum 2 years of Clinical Database (eCRF) Design experience in/for the pharmaceutical or medical device industry • Medidata Rave EDC Certified Study Builder • Excellent interpersonal, verbal, and written communication skills Nice-to-haves • Ability to work in fast-paced environment requiring support of multiple projects and customers simultaneously • High customer focus and ability to collaborate closely with global and cross-divisional partners • Skilled in organization and prioritization with a strong attention to detail • Solid understanding of clinical area and industry practices, techniques and standards Benefits • 401k • health_insurance • dental_insurance • vision_insurance • life_insurance • disability_insurance • paid_holidays • paid_volunteer_time • tuition_reimbursement • professional_development Apply tot his job