The Clinical Data Specialist, working with senior data management members, is responsible for the setup, documentation, implementation and locking of clinical study databases and clinical data for clinical studies to current regulatory and industry expectations and standards.

Duties and Responsibilities:

• Perform assigned activities related to data management per regulation and applicable standard operation procedures (SOPs)
• Contributes to the development, testing and locking 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
• Involved in reviewing and contributing to protocols from a data management perspective
• Involved in the management of the process from DMP development to data entry, data cleaning and data transfer, data lock to data export
• 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
• Creates data dictionary for data users
• Manages the medical coding process internally or through external vendors
• Develop, review and execute electronic data edit checks for web-based forms
• Performs quality control (QC) on study data and programs 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
• Perform third party non-CRF data management activities, including data transfers and Serious Adverse Event (SAE) Reconciliation
• Works collaboratively with other Pharmacokinetics staff, Biostatisticians, cross-departmentally within BPSI to meet project deliverables and timelines for clinical statistical programming and reporting
• Performs data entry as required
• 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
• BA or BS with a science or related background; equivalent experience in data management and a medical-related field may be substituted
• Understanding of database structures and database programming
• Knowledge of CDISC standards, especially CDASH and SDTM
• Knowledge of clinical trial processes and experience in, ICH GCP, and GCDMP (SCDM)
• Proficiency in MS Windows navigation, Word, Excel, 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