Clinical Project Director

About Us

GE HealthCare is a leading global medical technology and digital solutions innovator with over 100 years of healthcare industry experience and around 50,000 employees globally. We enable clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by our Edison intelligence platform. We operate at the center of an ecosystem working toward precision health - digitizing healthcare, helping drive productivity and improving outcomes for patients, providers, health systems and researchers around the world.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare - Creating a world where healthcare has no limits #LI-CM1

Areas of Responsibility & Tasks

• Ensure that study activities and milestones are planned, agreed, and achieved in line with the overall clinical development plan (CDP, if applicable), as well as milestone and recruitment plans.
• Determine the feasibility of running clinical studies in collaboration with relevant internal functions.
• Ensure the timely and accurate preparation of study documentation, including protocols, amendments, CRFs/eCRFs, study plans, and study reports, in collaboration with internal teams and CROs as required.
• Ensure that all Regulatory Authority and Ethics Committee submissions and approvals are obtained.
• Ensure that (Serious) Adverse Event ((S)AE) reporting is performed in compliance with internal procedures and external regulatory requirements.
• Provide clinical expertise to outsourcing specifications and purchasing activities to support RFP development and the selection of service providers and CROs.
• Participate in the selection of service providers, CROs, and other external vendors in collaboration with Sourcing, Strategic Alliances, and the study team.
• Select, supervise, and actively manage contractors, consultants, and external vendors involved in the clinical study (e.g. CROs, central labs, EDC vendors, ECG vendors).
• Build strong relationships to maximize performance and value delivered by service providers
• Foster a culture of joint accountability to ensure vendor performance
• Facilitate efficient and collaborative resolution of issues and conflicts with service providers
• Facilitate vendor training on applicable GE HealthCare SOPs.
• Perform initial investigator contact and participate in the assessment and selection of qualified investigators for clinical programs.
• Oversee pre-selection, initiation, monitoring, and closeout site visits.
• Oversee negotiation and tracking of site budgets in line with financial agreements.
• Oversee tracking of subject enrollment per site and provide management with clinical activity reports as requested.
• Ensure that clinical trial sites have adequate supplies to conduct the study.
• May supervise the work of less experienced study managers.
• Manage the clinical study budget.
• Attend monthly Clinical Research Meetings and report progress on assigned studies.
• Participate in the development, review, and harmonization of SOPs, guidelines, and forms.
• Identify and communicate opportunities for improvement within local and global Clinical Research infrastructure.
• In collaboration with the project team, lead proactive identification, assessment, and management of clinical study risks.
• Ensure that day-to-day clinical study operations comply with the Quality System and applicable regulations, maintaining continuous audit readiness.
• In collaboration with the Medical Director, identify study committee members (e.g. steering committees, publication committees), ensure contracts and charters are in place, and provide ongoing oversight.
• Attend Competent Authority and Ethics Committee study review meetings as required.

Qualifications

• Degree in a science-related field with extensive proven experience in managing complex Phase I–IV clinical studies within the healthcare industry.
• Excellent knowledge of all aspects of the clinical study process, including planning, execution, reporting, and publication of results.
• Strong written and verbal communication skills, with the ability to interact effectively at all organizational levels.

Skills & Attributes

• Excellent written and oral communication skills, strong interpersonal skills, and good presentation abilities.
• Highly organized and structured, with strong attention to detail.
• Ability to work independently and in a systematic manner.
• Diplomatic, cooperative, and effective team player.
• Decisive and solution-oriented mindset.
• Proven ability to manage complex studies and/or multiple studies across different regions.
• Demonstrated leadership skills.
• Willingness to travel as required for study team meetings, site visits, client presentations, and professional meetings or conferences.
• Flexible and adaptable approach.

Additional Information

Relocation Assistance Provided: No