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Olympus Corporation · 1 day ago

Director, Clinical Project Management

Center Valley, PA

Full-time

Hybrid

Director/Executive

$155K/yr - $233K/yr

10+ years exp

Olympus Corporation is a global medical technology company focused on advancing medical technologies and elevating the standard of patient care. The Director of Clinical Project Management will lead clinical studies project management, ensuring clinical projects are executed within scope, on-time, on-budget, and with high quality while collaborating with cross-functional teams.

ElectronicsIndustrialManufacturingMedical DeviceProduct Design

Responsibilities

In collaboration with the Global Clinical Operations leadership team, develop and implement a consistent and standardized approach to Clinical Project Management, leveraging integrated project plans to ensure clinical projects are executed within scope, on-time, on-budget and with high quality

Manage the Clinical Project Management team using proactive identification of resourcing needs, screening and hiring of candidates, training on departmental responsibilities and expectations, providing mentorship and guidance, fostering a culture of continuous learning and professional development

Ensure effective communication of study status, key performance indicators, and quality standards to ensure operational quality and efficiency

Align with Global Clinical Leads and Clinical Operations Management to ensure business unit expectations are clearly defined and met, ensuring appropriate change management as needed

Identify opportunities for process improvement and develop/implement best practices to enhance the efficiency and effectiveness of clinical trial operations

In close collaboration with Clinical Quality Affairs, develop and maintain Standard Operating Procedures (SOPs), Work Instructions, and templates to ensure consistent management of clinical operations in compliance with applicable regulations

Implements a regional outsourcing strategy as required to employ Contract Research Organizations (CROs), or other external vendors, in clinical studies and ensures management and oversight of the vendor(s)

Establish and oversee activities to ensure regulatory compliance across all project teams by establishing clinical research best practices, which are supported by quality procedural documents, standards, and tools

Ensure clinical studies are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards

As a member of the Clinical Operations leadership team, takes ownership of the Clinical Operations mission, objectives, and strategy over a 3- to 5-year time horizon, and is accountable to the Executive Director, Clinical Operations

Other duties as assigned

Qualification

Clinical Project ManagementClinical OperationsRegulatory ComplianceGlobal Regulations KnowledgeLeadership ExperienceCross-functional CollaborationProcess ImprovementBudget KnowledgeCultural AwarenessDocument ManagementSOP DevelopmentTraining SkillsCommunication SkillsStrategic ThinkingTeam ManagementMentorship

Required

BA/BS degree in life sciences or related field

Minimum of 10 years device/pharmaceutical industry experience in Clinical Operations with minimum of 5 years of direct experience in Clinical Project Management for pre and post-market trials required

Direct people management experience and managing teams. Demonstrated leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals

Experience in overseeing clinical operations' procedural documentation requiring a strong knowledge and application of global regulations, guidelines and standards (i.e., ICH E6 (R2), EU MDR, ISO 14155:2020) and good document management practices

Ability to think strategically, critically analyse and synthesize complicated data and scientific information

Strong communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration

Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required

Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization

Domestic and international travel up to 15%, including weekend and evening travel as needed to support business objectives and ongoing development of physician relationships

Scheduling flexibility to commit to a global weekly schedule (Tuesday – Wednesday – Thursday) navigating multiple time zones with extended hours into the early morning as well as late evenings