Senior Clinical Data Manager
This role will support the Director of Data Management across multiple oncology studies. This person must have a high attention to detail and be able to work across multiple projects.
Primary responsibilities of the Senior Clinical Data Manager are to perform and monitor ongoing data review for all clinical trials sponsored by the company and contracted to outside CROs. Responsibilities also include providing oversight of the work performed by the CROs and to provide guidance during study conduct from study start up through database lock.
Specific Responsibilities include:
• Act as Lead Data Manager across multiple study projects
• Attend internal and external project meetings
• Perform ongoing patient profile review
• Responsible for overseeing CRO Data Management
• Assist in study start-up activities (CRF design, UAT, edit checks review, etc.) and ongoing data management activities (e.g. reconciliations, data cleaning initiatives)
• Review protocols to ensure the data collection, database and reporting requirements can be met
• Perform data trend analysis and oversee data cleaning and database lock activities
• Assist in review of data management related documents prior to approval (data management plan, CRF Completion Guidelines, edit check specifications, coding guidelines, vendor management plans, etc.)
• Review CRF metrics reports against project data deliverables
• Maintain internal data management timelines
• Participate in internal team meetings and provide data management updates on assigned studies
• Provide vendor oversight as necessary. Acts as primary liaison with third party data vendors, EDC vendors.
Education / Experience / Skills
• Minimum BA/BS in scientific or health-related field.
• Minimum of 4 to 8 years of clinical data management experience in the pharmaceutical, biotechnology industry or in a CRO.
Oncology trial experience strongly preferred and global/international experience a plus.
• Proficiency with different data collection systems (e.g., IBM CD, Rave).
• Excellent communication (verbal and writing).
• Ability to multi-task and take on new responsibilities as needed in a fast-paced, small company setting.
• Experienced using Microsoft Office applications (Word, Excel, PowerPoint, etc.)
• Strong organizational skills and ability to prioritize tasks.
• Ability to work independently with minimal supervision.
• Will consider candidates with 3-5 years of experience with strong communication skills (verbal and written) and strong organizational skills
Work life balance
• Ability to work remotely 2 days per week after initial on-boarding (approximately 1-2 months)
• Flexible work hours/schedule