Director, Clinical Systems

Director, Clinical Systems

United States - California - Foster City Clinical Development & Clinical Operations Regular

Reporting to the Head of Clinical Systems, the Director, Clinical Systems provides functional leadership and technical oversight for technology solutions in support of Clinical Operations business needs. This role will provide thought leadership and partner with Clinical Operations, information technology groups to enhance and improve clinical systems and infrastructure. As a manager of direct staff reports, the leader will provide guidance, coaching, project prioritization, and participate in goal performance discussions.

Partner with the leadership to deliver future-state capabilities which lead to robust, scalable solutions to support clinical trial activities and that align to IT enterprise strategy and cost of ownership.

Manages multiple projects and teams supporting multiple business areas or our largest and most complex technical work streams.

This role will lead or participate in implementing strategic initiatives in collaboration with Clinical Operations and cross functional technical teams.

As Director of Veeva Clinical Vault owner (CTMS and eTMF) would be responsible for overseeing the implementation, configuration, and ongoing support of Veeva's CTMS and eTMF within life sciences companies, ensuring efficient clinical operations by optimizing system usage and aligning it with regulatory compliance, while collaborating closely with internal and external stakeholders to drive customer success with Veeva's clinical solutions.

Extensive knowledge in clinical trial operations and processes.

Provide technical support during regulatory inspections and internal audits.

Works with cross-functional Therapeutic Areas, R&D IT leaders to develop the short- and long-range technical strategy and roadmap for assigned business areas or key technical work streams, including liaison with IT to schedule changes and updates.

Be a change advocate, by stewarding and pioneering activities which focus on automation, simplification of processes and system design, and seeking methods to ensure strong interoperability amongst the larger clinical ecosystem.

Leads definition and design and oversees implementation and execution of multiple initiatives within the assigned area, including appointing project teams and act as a technical leader.

Act as the technical leader and spokesperson to cross-functional leaders and teams.

Oversees and guides systems applications and other solutions development and configuration, including guiding the technical solution architecture when needed.

Oversees user or processes activities, including refining applications or other solutions to align with business process needs, including the definition and implementation of the short- and long-range technical roadmap for all data science deliverables owned by the team.

Ensures business processes are created or updated and maintained to align with business and information systems needs and compliance requirements.

Ensures timely, accurate and appropriate development and delivery of technical documentation and business process documentation.

Partner with quality and the computer systems validation organization to ensure validation of GxP-related system activities are completed in compliance with regulatory requirements.

Travels nationally and internationally as required.

Bachelor's Degree and Twelve Years’ Experience

OR

Masters' Degree and Ten Years’ Experience

OR

PhD and Eight Years’ Experience

Minimum of 6 years’ technical project management or other relevant leadership experience in a business environment, including multiple years’ managing project teams.

3+ years’ line management (direct reports) experience.

Demonstrated excellence in complex technical project management and effectively managing multiple projects and priorities.

Proven ability to lead multifunctional regionally distributed teams, and to manage and develop employees.

Demonstrated excellence in forging and maintaining collaborative, positive and long-lasting partnerships with system stakeholders: functional…