The Clinical Data Manager is responsible for and will perform the day to day tasks associated with maintaining a clinical database.
• Responsible for overseeing up-to-date and quality data entry into electronic data capture system (EDC) by clinical sites.
• Responsible for tracking completion of source worksheets.
• Perform remote source data verification.
• Work with Project Manager and Monitors for query resolution; abstracts data from necessary sources to complete the EDC and resolve queries.
• Responsible for maintaining key clinical study data for reporting to the Chief Clinical Officer and the clinical team.
• Provide status updates on data entry and data quality metrics.
• Maintain working knowledge of protocol (and associated amendments) for effective collection of data and effective communication with clinical sites as needed.
• Support the preparation of data reports.
• Adhere to data security and confidentiality requirements when handling confidential data.
• Provide support in maintaining and archiving clinical study documents.
• Perform data management study close-out activities including final reconciliation and quality control steps in accordance with Medicenna SOPs.
• Ensure approved study documentation is maintained and properly stored in the trial master files.
• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
• Other duties, as assigned.
• BS or MS in Life Sciences or technical degree and at least 3 years data management experience or clinical research experience in pharmaceutical or CRO is preferred
• Associates degree with minimum 5 years data management experience
• Experience with computer data entry and database management
• Experience with Electronic Data Capture (EDC) system(s) is required
• Oncology therapeutic area experience is preferred
• Ability to interpret diagnostic imaging, pathology, hematology, oncology related reports
• Ability to work independently and resolve issues
• Must have strong attention to detail and accuracy
• Have a strong understanding of clnical trials
• Excellent organizational skills
• Must be flexible and able to work in a face-paced environment
• Proficiency in medical terminology (oncology)
Please email your resume to firstname.lastname@example.org and reference Clinical Data Manager in the subject line.