Executive Director - Clinical Systems

October 26

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pfm medical, inc.

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Medical Device Manufacturing

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Description

• Due to our continued growth Precision for Medicine is hiring an Executive Director, Clinical Systems to join our team. • Candidates can work remotely in UK, Spain, Poland, Hungary, Romania, Serbia, or Slovakia. • The Executive Director, Clinical Systems is responsible for the development of the strategic direction for technology development and implementation to drive efficiencies. • The Executive Director oversees a team dedicated to selecting, deploying and managing clinical systems. • Further, this role collaborates across multiple stakeholders to ensure the selection and adoption of clinical systems that meet the functional needs to deliver services on clinical studies. • Develop and maintain a Clinical Systems Strategic Roadmap outlining the needs, sequencing and timing for delivering key business capabilities and enhancements to clinical systems. • Collaborate with key stakeholders to ensure the use of change management strategies that maximize employee adoption and usage of clinical systems and minimize resistance. • Partner with Precision IT Business Relations Managers to ensure integration of applicable system roll-outs. • Work with stakeholders across Clinical Solutions to evaluate, select and implement clinical systems that support business and operational requirements across all functional areas. • Lead performance and volume metrics and escalating any existing or projected Program risks to meeting service level agreements. • Manage end user system support functions according to service level agreements, including: facilitation of Precision user access process, triaging end user workflow/data entry issues, maintaining user SOPs and training materials. • Establish and manage team(s) that perform high-volume operational tasks within Precision. • Partner with Precision IT for the technical management and support of clinical systems. • Plan for technical maintenance and upgrades and assure business impacts are assessed and communicated to appropriate stakeholders. • Plan Department growth to address the backend management needs of clinical systems to ensure all systems are operationalized in a timely manner to meet Sponsor deliverables. • Recruit, train, motivate and manage department staff. Develop and mentor staff based on goals, accountability, objectives, and priorities. • Manage the process and oversight of system access for all clinical systems within the remit of this position.

Requirements

• Bachelor’s Degree • 15+ years of clinical research experience, includes relevant experience managing clinical research or enterprise system, transactional process operations, and service delivery • Familiarity with a comprehensive range of clinical systems and system requirements. • Demonstrated strong governance management in a matrixed setting, including the abilities to inform strategic decisions, to facilitate and negotiate through complex strategic decisions, to communicate with executive leadership, and to influence without authority when necessary. • Solid foundation in data governance principles and experience managing large systems. • Working knowledge of ICH-GCP guidelines and major Health Authority regulations as they pertain to the operational aspects of clinical studies and the management of clinical. • Experience working in a Clinical Research Organisation or Pharmaceutical company • Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects • Working knowledge of clinical operations workflows; some knowledge of study management and reporting needs • Proven ability to collaborate in a team environment and work independently • Excellent oral and written communication skills • Be able to communicate effectively in the English Language • Must be a team-player, punctual and reliable, dependable, and flexible in adapting to change in a multi-disciplinary, fast-paced work environment • Proven ability to establish productive working relationships across large organizations, communicate well at all levels, and to work collaboratively in a highly-matrixed reporting environment to build strong partnerships. • Strong technical skills • Experience in Risk Based Quality Management