Department: Clinical Research & Data Management

The Clinical Data Manager will support the Data Management group from study start-up through database lock and clinical study report using EDS and Statistical tools. The successful candidate will deliver high quality data, on time and on budget. In this role, the candidate will be expected to lead and provide oversight for the execution of data management activities for more than one compound in a therapeutic area.

Responsibilities:

• Design and develop electronic Case Report Forms (eCRFs) for Inform database during study start-up activities.
• Conduct requirement workshops with key stakeholders to collect the opinion on what data can be collected and how it should be collected in the electronic case report form of the database
• Conduct surveys and receive the feedback from data management team & Clinical operations team on the report.
• Build and test the Case report forms based on the finalized study requirements.
• Run Reports in InForm/J-review for data interpretation and analysis to identify query and SDV (source data verification) metrics.
• Create tables, listings and graphs with the subject data to ensure the data conformance with study protocol and identify data quality issues & trends.
• Work with the data stewards and remediate the data quality issues.
• Performing user acceptance testing of the database using Inform.
• Review the User acceptance test scenarios and provide the feedback to testing team
• Perform User acceptance testing for the key scenarios.
• Perform predictive modeling so that outcome of the future trials can be predicted.
• Apply appropriate mathematical and statistical theories to determine the next steps based on current indications of the clinical trial.
• Provide the conclusions from the study to support to strategic collaboration executive decision making
• Resolving data issues from clinical, SDTM, and Biostatistical groups
• Conduct the defect triage meetings with cross-functional teams to prioritize the data issues.
• Perform the deep dive data analysis and identify the resolutions for the reported issues.
• Review the resolutions with cross-functional teams and incorporate the feedback.
• Fix the data in the database using database queries based on the finalized resolution strategy.
• Identify the key data attributes that are important for Clinical study using Statistical Analysis Tool (SAS).
• Work with Clinical Research organizations (External Vendors) to collect the data as per the data transfer specifications.
• Coordinating with Programming team to provide support to the data review and safety updates (coordinate generation of data review listings, data retrieval to support data review and analysis, SDTM (Study Data Tabulation Model).
• Determine the model for addressing data reconciliation
• Finalize the data reconciliation strategy

Educational and/or experience requirements:

• Bachelor’s degree of Science in Statistics/Pharmacy
• Strong experience with EDC (Rave preferred), full development life cycle
• Well-rounded technical skills: EDC, SAS, and CDISC
• Working experience handling lab/image data
• Strong understanding of clinical trials, pharmaceutical operations, and regulatory compliance
• Practical knowledge of ICH, FDA, and GCP regulations and guidelines
• Accuracy and attention to detail working with clinical data
• Good planning, project management and organizational skills

Job Type: Full-time

Salary: $100,000.00 to $120,000.00 /year

Please send profile at info@zenithlifescience.com for direct consideration or question.

• Posted on 08/16/2022