Executive Director, Clinical Systems

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.

Position Summary: 

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.

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

• 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.  Work in partnership to 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.

Qualifications: 

Minimum Required: 

• 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.

Other Required: 

• 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

Preferred: 

• Master’s Degree
• Experience working with vendors, including both software, and consulting services.

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease.

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