Senior Clinical Trials Coordinator — Hybrid Leader & Mentor

Olympus Corporation; Center Valley (Lehigh County); Hybride; USD 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

Competitive salaries and annual bonus

401(k) with company match

Comprehensive medical, dental, vision

24/7 Employee Assistance Program

Wellbeing programs and paid time off

Paid parental leave

12 paid holidays

On-site daycare and facilities

Résumé du poste

Olympus Corporation is seeking a Senior Clinical Trial Coordinator to lead coordination of multiple clinical studies under the Dir. Clinical Projects. You will oversee study documents, TMF maintenance, and regulatory binder creation while mentoring junior team members in a hybrid work setting.

You’ll support budgets, site communications, investigator meetings, and EDC training, ensuring compliance with clinical study regulations and Olympus SOPs. Travel up to 10% is expected.

Qualifications

• Minimum of 1 year of experience in medical device, biotech, or pharmaceutical company.
• Ability to support multiple projects for Olympus Clinical Affairs teams at different locations.
• Well organized, detail oriented, and accountable.
• Strong written, oral, and interpersonal communication skills.
• Flexible, self-motivated and works well under pressure in a dynamic environment.

Responsabilités

• Coordinates and supports activities for multiple studies under the direction of the Dir. Clinical Projects.
• Assists Clinical Affairs team with development of study specific documents.
• Responsible for setup, maintenance, and archival of the TMF.
• Collects and tracks regulatory documents for multiple studies for TMF completeness and audit readiness.
• Supports drafting of CTA, budget, and CDA requests.
• Creates study-specific Regulatory Binder and ships to sites.
• Manages study payments with vendors and sites per budgets.
• Tracks payments and interfaces with Finance on accruals.
• Communicates with principal investigators, hospital staff to coordinate studies.
• Supports study meetings and drafts minutes.
• Assists in remote/on-site study monitoring.
• Assists site training for EDC or protocol as needed.
• Designs and updates study newsletters and circulates final docs to sites.
• Responsible for device/equipment shipments, accountability, and reconciliation.
• Maintains Sunshine Act reporting records and updates Transparency Reporting team.

Connaissances

Attention to detail

Multitasking

Strong communication

Travel up to 10%

Formation

Associate’s or Bachelor’s degree in science/healthcare/business

Outils

MS Word

MS Excel

MS Outlook

MS PowerPoint

EDC systems

Description du poste

Olympus Corporation is seeking a Senior Clinical Trial Coordinator to lead coordination of multiple clinical studies under the Dir. Clinical Projects. You will oversee study documents, TMF maintenance, and regulatory binder creation while mentoring junior team members in a hybrid work setting.

You’ll support budgets, site communications, investigator meetings, and EDC training, ensuring compliance with clinical study regulations and Olympus SOPs. Travel up to 10% is expected.