Senior Director Global Data Management

Position Summary:

The Senior Director, Global Data Management will provide leadership and clinical data expertise to internal and external stakeholders and oversee PFM Global Data Management efforts across all global laboratory sites. The successful candidate will have a good knowledge of the end-to-end clinical research and Data Management processes, as well as global regulatory and industry rules and guidance’s (i.e., CLIA, ICH, GLP, and GCP) to support drug development processes and global commercial sample testing. This role is responsible for managing all Data Management teams globally for PFM, as well as all vendors providing services to PFM. The leader in this role will support the design and implementation of an end-to-end data management life cycle and partner with cross-functional leadership to build and deploy analytic capabilities that enable PFM to operate in a paperless environment by deploying the approach tools.

 

Essential functions of the job include but are not limited to:

• Oversee all day-to-day Data Management activities, timelines, and deliverables for clinical trials from study start to database lock and delivery of data analyses.
• Lead the innovation, design, implementation, and life cycle management of all data science and analytics solutions across PFM aimed at leveraging technology and automation to implement intelligent data management services across PFM laboratory network.
• Responsible for end-to-end Clinical Data Management activities and serve as the primary point of contact for internal and external study team members.
• Represent Data Management on cross-functional teams, providing accurate study status updates, timelines, and proactive communication of Data Management risks.
• Contribute to the identification and selection of Data Management vendors through due diligence and proper vetting of vendor proposals.
• Lead initiatives in deployment of the state-of-the-art IT solutions to get better value of data, exploration of internal and external data sources, designing demand analytics visualizations to provide new insights and experimentation of automation to improve efficiency in data delivery and data management.
• Manage the portfolio of systems and tools used in data science (approximately 10-15 systems), including annual planning and prioritization of DS system investments.
• Create business cases for system upgrades or new systems, demonstrating quantitative benefits.
• Provide solutions to reduce the time from data generation to data reporting for accelerate client decision making.
• Develop and maintain data transfer agreements with external data vendors (e.g., clinical laboratories, imaging vendors). Manage interactions with outside vendors on collection, transmittal, and transfer of study-specific data.
• Partner with Data Management service providers (e.g., EDC vendor, labs, imaging vendors, CRO/FSP) to ensure agreed-upon performance on quality and timeliness of deliverables.
• Responsible for ensuring data collected meets the requirements of the study objective and quality standards. Manage data query process for inconsistencies, omissions, or errors.
• Maintain all Data Management internal files, ensuring preparedness for regulatory inspections.
• Contribute to the development, maintenance, review, and revision of SOPs, guidelines, process maps, Work Instructions, and templates to support department and oversight models.

 

Qualifications:

 

Minimum Required:

• Minimum of 15 years of related experience in Data Management for Pharmaceutical/biotech/CRO with expertise in the cross-functional interfaces with the Data Management function with a Bachelor’s degree; or 12 years and a Master’s degree; or a PhD with 8 years’ experience; or equivalent experience.
• 10 years of healthcare industry experience with significant knowledge of and experience with clinical data capture, warehousing, and analytics tools (EDC, eCOA, SAS, R, clinical workbench, visualization tools etc) and experience managing a suite of relevant systems and staff with accountability for managing budgets, timelines and resources.

 

 

Other Required:

• Practical knowledge of ICH, FDA, GLP, GCP, and CAP/CLIA regulations and guidelines

• Clinical & quality experience in supporting global clinical trial studies as part of the drug development, post marketing commitments or patient testing under CAP/CLIA.
• Proven track record of on-time and high-quality Data Management deliverables.
• Demonstration of excellent communication skills in writing and in interactions with colleagues.
• Direct experience in managing offshore resources as an extension of a project team.