Director Clinical Data Management

Mainz, Germany; Cambridge, US; Gaithersburg, US   |   full time   |   Job ID: 9120 

 

 

As a Director of Clinical Data Management, you will be responsible for the effective leadership, strategic planning, and oversight at the portfolio level within the Global Clinical Data Management function. In this role you will ensure the execution and alignment of the data management strategy at the portfolio level to meet evolving business needs. You must have sufficient understanding of regulations and GCP requirements for drug development, advanced knowledge of Electronic Data Capture/related applications and industry standards, and advanced skills partnering with CROs and other third-party vendors. This position requires working cross-functionally with other key stakeholders and leading DM activities to support regulatory submissions and inspections. You must have experience s as a people manager across global teams.

 

Job Responsibilities

• Supports Senior Director of Clinical Data Management and peer Directors to build out processes necessary to identify, evaluates and executes on functional growth opportunities. 
• Liaises with various internal and external groups (Clinical Development, Clinical Operations, Statistics, Statistical Programming, Pharmacovigilance, and external vendors including CROs) for the implementation of data management activities needed for clinical studies within his portfolio. 
• May represent Data Management in governance bodies externally with CRO partners and stakeholders, and internally in Core teams. 
• Serves as the Data Management Subject Matter Expert representing R&D during regulatory inspections and submissions, and internal audits pertaining to R&D activities within his portfolio. 
• Contributes to departmental SOP and process development and improvement, and integration of technology; support GCP inspection readiness.
• Provides strong leadership within and across Data Management platforms. Facilitates internal information sharing to promote learning and best practices. 
• Identifies major themes and escalates unresolved data or compliance issues to the functional manager(s). 
• Hires, develops, and retains talents. Responsible for the performance management of the Data Management function, including performance of outsourced data management activities. Line manager of CDM staff, accountable for the recruitment, development and succession planning of staff. 
• Provides highest level of CRO/vendor oversight to ensure project plans are executed with high quality. 
• Ensures functional contracts are compliant with financial processes. Acts as a point of escalation. 
• Provides oversight and leads the efforts to implement and develop Data Management processes and tools based on emerging trends, technology, and best practices. 
• Champions Data Management and related expertise to promote best practices across the Drug Development lifecycle.
• Updates skills continually with respect to evolving industry standards, best practices, and therapeutic area knowledge. 
• Provides input to and help develop short-term and long-term strategies to improve vendor oversight practices 
• Provides input on vendor and technology evaluation, selection, and utilization that aligns with scopes of work 
• Oversees and manages the portfolio clinical data management activities and ensures consistency across the different trials within his program; ensures the development and readiness of personnel to deliver on existing programs 
• Maintains continual engagement at the core team and portfolio level to assess needs and build/maintain a capability for data management and analytics 
• Leads systematic professional development and provides strong support for direct reports and other members of the Clinical Data Management portfolio. 
• Supports significant levels of business change, within own organization and across the broader organization, e.g. standardization

 

Required Qualification, Skills and Experience

• Natural / life sciences, scientific, or bioinformatics / computer science background (university degree) or former experience in a CRO/ biotechnology/ pharmaceutical company in a Clinical Data Manage