Senior Clinical Data Co-ordinator

Work as a Senior Data Manager across multiple clinical studies; supporting data management activities; validating clinical data to excellent quality whilst adhering to deliverable timelines. Good knowledge of CDASH implementation guidelines; producing reviewing and updating data handling manual; creating eCRF specifications building and User

Acceptance Testing of clinical databases. Mentoring Data Coordinators in their work performing senior review of data management documentation and output deliveries providing oversight and advising on best practices approach to clinical data processing. Creating and reviewing SOPs; tracking performance metrics; involvement in CAPA processes and ensuring implementation of quality processes. Act as a subject matter expert. Preparation of proposals and quotes and change orders for prospective and existing clients.

Responsibilities

• Preparing stable draft eCRF specification for database build. Finalising eCRF specification and obtaining approvals. Performing QC of eCRF specification. Creating project level or therapeutic area level standards
• Preparing eCRF UAT scripts and performing UAT according to scripts. Creating standard CDASH eCRFs from a library
• Creating study specific / complex eCRFs. Checking protocol requirements are met. Approving release of database. Performing senior review summary of UAT findings for complex studies
• Specifying edit checks and performing senior review of the Data Review Conventions. Preparing edit check UAT scripts and performing UAT according to scripts. Programming study specific / complex edit checks
• Producing and reviewing data listings for data anomalies and performing sight review of eCRF data
• Reviewing edit check outputs and actioning as appropriate. Actioning data query responses. Raising manual data queries within the study database. Resolving issues arising with data queries
• Reviewing and entering normal ranges for local laboratory data managing annual updates and raising issues with sites on local laboratory data
• Defining and generating key study metric reports for periodic review by client including QC. Overseeing progress of data entry by sites monitoring by CRAs and responses to data queries
• Producing key study metric reports and KRIs for RBM approach. Reporting monitoring and mitigating actions in the issues tracker
• Preparing performing senior review / QC and updating documents for the data handling manual. Performing senior review of data handling manual and giving advice for complex study procedures. Compiling all documents in the DHM and obtaining client approval
• Assigning dictionary codes to medical terms performing QC of coded terms and reviewing coded data listings for consistency. Liaising with study Medical Physician to resolve coding issues
• Preparing documents for third party data performing senior review QC and update of those documents. Establishing test and live data transfer processes through liaison with third party vendors. Liaising with third party vendors and / or client for resolution of process or contract issues
• Reviewing reconciliation outputs and resolving data issues with client and / or third party vendors

Qualifications

• Life Science degree nursing qualification or equivalent experience
• Experience within the pharmaceutical industry to have a good awareness of clinical trial issues design and implementation GCP and regulatory requirements
• Good experience of data management software systems and coding dictionaries including MedDRA and WHODrug
• Extensive experience of leading data processing activities within a regulated environment

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