Manager, Clinical Data Management

Job Description
We are seeking a Manager to Lead Clinical Data Management (CDM) activities for clinical studies or a clinical program. 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 highly 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. 
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 
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) 
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