Principal Clinical Project Manager - Remote

Olympus Corporation of the Americas; United States; Remote; USD 117,000 - 164,000; Full time

Job summary

Join a forward-thinking company as a Principal Clinical Project Manager, where you will lead and oversee complex clinical trials that make a real difference in patient care. This role offers the opportunity to work with cross-functional teams, manage significant budgets, and ensure compliance with regulatory standards. You will be instrumental in driving project success while enjoying a flexible work environment and a competitive compensation package. If you're passionate about advancing healthcare and have a proven track record in clinical project management, this is the perfect opportunity for you.

Benefits

Competitive salaries

Annual bonus

401(k) with match

Comprehensive medical coverage

Dental coverage

Vision coverage

24/7 Employee Assistance Program

Generous paid time off

Parental leave

On-site amenities

Qualifications

• 12+ years of clinical trial management experience or equivalent.
• Deep understanding of clinical trial regulations and guidelines.

Responsibilities

• Leads planning and execution of large-scale clinical trials.
• Manages clinical trial budget and ensures audit readiness.

Skills

Effective communication skills

Problem-solving skills

Organizational skills

Understanding of GCP and FDA regulations

Experience managing cross-functional teams

Conflict resolution skills

Education

Bachelor’s degree in health sciences or related field

MS/MPH degree in life sciences or related field

Tools

EDC

MS Word

Excel

PowerPoint

MS Project

Job description

Principal Clinical Project Manager - Remote

1 week ago Be among the first 25 applicants

Field

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.

Working Location: NATIONWIDE

Workplace Flexibility: Field

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus.

Job Description

The Principal Clinical Project Manager (CPM) is responsible for assisting with the execution of high-quality clinical studies and will focus on the oversight and monitoring of investigational data to ensure compliance.

Job Duties

1. Leads and drives the project team in the planning, execution and management of all operational aspects of large-scale, complex, and/or business critical clinical trials including but not limited to:

• Data management activities such as query generation and resolution, and reporting of adverse events and protocol deviations.
• Development and implementation of site corrective actions as needed to address any compliance issues.
• Study training for investigators and coordinators, contract research organization (CRO), Data and Safety Monitoring Board (DSMB) and/or Clinical Events Committee (CEC), or core labs.
• Site qualifications, activations and initiation processes, including budget and contract management and review of site activation documentation.

Leads, directs and executes clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.

Tracks development of and collaborates with the project team on all internal and external project materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions.

Owns and manages the clinical trial budget including developing the budget, forecasting, and accruals.

Ensures the project team maintains a continuous state of audit readiness.

Prepares study related documents including clinical protocols, informed consent forms, case report forms, monitoring plans, study manuals, and other study related tools.

Manages partnership with CRO and other external vendors.

Leads the proactive identification, assessment, and management of clinical study risks, in collaboration with the project team.

Informs and presents study progress and known risks to Senior Leadership.

Provides clinical input to product development activities; may represent Clinical on product development teams.

Facilitates the planning of, and preparing materials for, investigator and coordinator meetings.

Ensures that appropriate resources (personnel, tools, etc.) are maintained for Quality System compliance and audit readiness.

May coordinate, schedule, and conduct monitoring visits at investigational sites to ensure compliance to the clinical protocol, regulations, and timely receipt of data including source document verification, writing or reviewing monitoring reports and follow up letters, and device accountability.

Mentors and coaches all levels of the Clinical team.

Job Qualifications

Required:

• Effective communication skills, both oral and written, with high emotional intelligence.
• Proficient in computer skills (EDC, MS Word, Excel, PowerPoint, MS Project, etc.).
• Strong organizational skills with high attention to detail and accuracy.
• Problem-solving skills, both collaborative and individual.
• Deep understanding of GCP, FDA regulations, ISO regulations, and current industry practices for clinical trials.
• Experience in coordinating, prioritizing, and multi-tasking with timelines.
• Professional demeanor and appearance.
• Ability to communicate effectively with all levels of leadership.
• Conflict resolution, influence, and relationship-building skills without formal authority.
• Ability to work independently and manage multiple tasks in a fast-paced environment.
• Experience managing cross-functional teams.
• Willingness to travel domestically up to 40%, some international travel up to 10%.

Preferred:

• Experience with medical device trials.
• People management experience.
• MS/MPH degree in life sciences or related field.
• Bachelor’s degree in health sciences or related field plus 12+ years of clinical trial management experience or equivalent.
• Experience managing scope, budget, and timelines.
• Leadership skills, influencing teams.
• Participation on product development teams.
• Proven track record of delivering projects with broad impact.
• Experience solving complex business problems.
• Financial acumen and budget management experience.
• Expertise in complex clinical research guidelines (e.g., 21CFR 312/812, ISO 14155, GDPR, GCP).

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

• Competitive salaries, annual bonus, 401(k) with match.
• Comprehensive medical, dental, vision coverage starting immediately.
• 24/7 Employee Assistance Program.
• Wellbeing programs, generous paid time off, parental leave, and more.
• On-site amenities and flexible work environments.

Learn more about our benefits and incentives.

The base pay range is $117,068.00 - $163,896.00/year, plus potential bonuses. Compensation factors include experience, location, education, and certifications.

Olympus is committed to improving lives and advancing healthcare through innovative solutions, with a global presence and a commitment to diversity and inclusion.