Essential Duties and Responsibilities:
- Manage all aspects of the clinical trial data management process from study start-up to database lock for Aclaris’s clinical trials.
- Serve as a member of Clinical Study Teams and act as primary Data Management contact and contributor for assigned projects.
- Oversee CROs, EDC vendors and other third-party vendors in a project manager capacity in support of timelines and data-related deliverables.
- Monitor timelines and ensures that clinical data management deadlines are met with quality.
- Perform UAT for database and test according to UAT Plan.
- Specify requirements for data management documentation, electronic and manual edit checks created by CRO.
- Review and approve electronic and manual edit checks created by third party vendors.
- Review and approve data management documentation created and maintained by third party vendors.
- Ensure that all medical coding is performed on an ongoing basis throughout the life cycle of the program and at the end prior to database lock.
- Ensure the proper data transfers are conducted (central lab data, ECG data, patient reported outcome data, etc.).
- Create and maintain electronic and manual edit check specifications for internal studies.
- Create and maintain data management documentation for internal studies.
- Oversee the review of clinical trial data to identify erroneous, missing incomplete, or implausible data.
- Review and provide feedback on protocols.
- Ensure adherence to data management standards.
- Provide written and/or verbal status reports to department and project team.
- Provide data management input to Requests for Proposal.
- Review vendor proposals, work orders and contracts.
- Serve as the data management subject matter expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables and resource requirements.
- Manage multiple projects.
- Identify and troubleshoot operational problems, issues, obstacles and barriers for studies based on metrics data, and input from project team members.
- Participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.
- Investigate, evaluate, and implement new technology solutions.
- Participate in projects / initiatives on request or take on department-wide tasks to contribute to the optimization of processes within the department.
- Due to COVID, employees are required to work remotely but will transition back to a professional office environment.
- This role routinely uses standard office equipment such as computers, phones, and photocopiers.
- This position is required to work occasional nights and weekends to meet company demands.
- Occasional overnight travel to investigator sites or Site Initiation Meetings may be required.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.