Position Summary The Clinical Data Associate, working with senior data management members, is responsible for entering clinical study data into an electronic database(s), setup databases, data cleaning/query management and documentation of clinical study databases and clinical data for clinical studies to current regulatory and industry expectations and standards.

• This is a part-time position with an average of 20 hours per week. Must be available between Monday-Friday during core business hours, 9:00 am to 5:00 pm.

Duties And Responsibilities

• Perform assigned activities related to data management per regulation and applicable standard operation procedures (SOPs)
• Contributes to the development and testing of study specific databases and clinical study data for mainly Phase I and BA/BE clinical studies and potentially for Phase II-IV clinical studies
• Editing, processing (data entry) and entry of data into an electronic database from relevant clinical study documentation (e.g., Case Report Forms, Source Documentation)
• Resolution of database queries, as generated in real-time or following completion of all planned data entry
• QC review of entered clinical trial data to ensuring accurate and precise entry of all data
• Identifying issues and queries with study documentation and bringing this to the attention of the direct supervisor (or designate)
• Adherence to study timelines
• Performing all work in accordance with BSPI Standard Operating Procedures, relevant regulatory guidelines and study requirements
• Involved in the management of the process from DMP development to data entry, data cleaning and data transfer
• Contributes to or writes the Data Management Plan (DMP) and other data management documentation
• Design and review eCRFs according to the study protocol, set up database, perform user acceptor testing (UAT) and lock database and study data
• Performs quality control (QC) on study data as needed
• Create, review, and process data queries and updates the database
• Query data inconsistencies and revise case report forms in compliance with SOPs, client guidelines and regulatory agency guidelines
• Other duties & responsibilities as required

Qualifications

• Experience in data entry or Data Management activities, performing activities in relationship to setup, conduct and locking of clinical data
• Understanding of database structures and database programming
• Knowledge of clinical trial processes and experience in, ICH GCP, and GCDMP (SCDM)
• Proficiency in MS Windows navigation, Word, Excel, Adobe, PowerPoint, and email applications
• Strong analytical and problem solving skills
• The ability to multi-task and prioritize are essential
• Strong oral and written communication skills
• Self-motivated, with the ability to learn quickly and independently

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