Sr. Manager, Clinical Data Management
3 weeks ago
We are seeking a Senior Manager to lead Clinical Data Management (CDM) activities for clinical studies or clinical program(s). This position will report to the Associate Director/Director of CDM and work on-site at our Waltham, MA office. Deciphera embraces a flexible workplace. You will work out of our Waltham, Massachusetts office. Deciphera expects a minimum number of in-office days. Specific days spent in the office should be determined in conjunction with your manager.
What You’ll Do:
May simultaneously function as lead CDM for multiple clinical trials or oversee the data management across a program
Accountable for the data quality and data integrity for complex or pivotal clinical studies
Oversee the work of the outsourced CDM vendor for assigned projects
May contribute to vendor selection and management to ensure performance is consistent with Deciphera standards.
May review invoices
Forecast timelines and resources required to complete study-specific tasks on time and with high quality
Work collaboratively with stakeholders in Medical Affairs, Regulatory, PV to determine dates of program data deliverables.
Provide guidance on clinical data management to CDM staff, study teams, vendors, and management
Manage the escalation of study related issues and communicate as appropriate with management
Present ongoing study updates to management
May supervise one or several CDM staff members
Plan the data acquisition for the clinical studies in the program, ensuring the computerized data systems are adequate and fit for purpose and the testing aligns with the risk and criticality of the data and the validation needs of the computerized data system
Ensure the activities described in the Data Management Plan (DMP) are executed in accordance with the DMP, including data acquisition, data transfer, data reconciliation and review, medical coding, data extract and rolling data freeze, data lock and database lock
Ensure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracy
Lead inspection activities for CDM and manage any findings to resolution.
Active participant in the development and revision of Standard Operating Procedures (SOPs)
Define metrics to measure clinical trial database quality, site and vendor performance and implement those metrics in the clinical trials
Analyze metrics across projects and programs; escalate or inform management and cross functional colleagues to trends.
Facilitate resolution of operational problems, issues, obstacles and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.
Assist with development of therapeutic area standards for Case Report Forms and Edit Checks
Assist in the coordination of the acquisition and development of tools to support data management tasks internally and externally with DM vendors; this may include development of specifications, validation documentation or perform validation
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