Director, Platform Lead, Clinical Data Management

Open for hire at one of the following locations –  Cambridge Erie Street. - Job ID: 7055 

 

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Director, Platform Lead, Clinical Data Management 

 

Responsibilities

 

As Director, Platform Lead, Clinical Data Management, you will be responsible for the effective leadership, strategic planning, and oversight at the platform 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 platform 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.

 

• Supports Director/Senior Director of Clinical Data Management to manage portfolio level DM strategies and execution.

• 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/her platform.

• 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/her platform.

• Contributes to departmental SOP and process development and improvement, and integration of technology; Support GCP inspection readiness.

• 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 at platform level, 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.

• Contribute to 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 platform clinical data management activities and ensures consistency across the different trials within his/her program; ensures the development and readiness of personnel to deliver on existing programs

• Maintains continued engagement at the core team and platform level to assess