Principal Clinical Project Manager - Remote

Olympus Corporation of the Americas; United States; Remote; USD 128,000 - 181,000; Full time

Job summary

An established industry player is seeking a Principal Clinical Project Manager to oversee and ensure compliance in high-quality clinical studies. This role is pivotal in leading project teams, managing budgets, and ensuring audit readiness while collaborating with cross-functional teams. The ideal candidate will have extensive experience in clinical trial management, particularly within medical devices, and will thrive in a fast-paced environment. Join a company that values innovation and integrity, offering competitive salaries and comprehensive benefits, as you contribute to advancing medical technologies and improving patient care.

Benefits

Competitive salaries

Annual bonus

401(k) with company match

Comprehensive medical coverage

24/7 Employee Assistance Program

Wellbeing programs

Paid Vacation and Sick Time

Paid Parental Leave

On-Site Childcare

Fitness Center

Qualifications

• 12+ years of clinical trial management experience or equivalent.
• Experience with medical device trials preferred.

Responsibilities

• Leads and manages operational aspects of complex clinical trials.
• Prepares study-related documents and manages clinical trial budget.

Skills

Effective communication skills

Proficient in computer skills

Strong organizational skills

Knowledge of Good Clinical Practices (GCP)

Ability to work independently

Problem solving

Ability to resolve conflict

Education

MS/MPH degree in life sciences

Bachelor’s degree in health sciences

Tools

Electronic Data Capture

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

MS Project

Job description

Principal Clinical Project Manager - Remote

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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

1. 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 reports 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 excellent interpersonal and diplomacy skills and high emotional intelligence.
• Proficient in computer skills (Electronic Data Capture, Microsoft Word, Excel, PowerPoint, MS Project, etc.)
• Strong organizational skills with high attention to detail and accuracy
• Skilled at collaborative and individual problem solving
• Strong knowledge of Good Clinical Practices (GCP), FDA regulations, and current industry practices related to clinical trials, including applicable ISO regulations for global trials
• Experience in coordinating, prioritizing, setting timelines, and multi-tasking
• Professional demeanor and appearance
• Ability to create and deliver communication tailored to all levels of leadership
• Ability to resolve conflict, influence teams, and build relationships without formal authority
• Ability to work independently and manage multiple tasks in a fast-paced environment
• Ability to work effectively with cross-functional teams
• Willingness to travel domestically up to 40%, with 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 with 12+ years of clinical trial management experience or equivalent
• Experience managing scope, budget, and timeline
• Leadership experience, either direct or indirect
• Participation on product development teams representing Clinical
• Proven track record of delivering projects with broad business impact
• Experience solving complex business problems
• Financial acumen, especially in clinical trial budget management
• 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.

Benefits include:

• Competitive salaries, annual bonus, and 401(k) with company match
• Comprehensive medical, dental, and vision coverage from day one
• 24/7 Employee Assistance Program
• Wellbeing programs, Paid Vacation and Sick Time, Paid Parental Leave, Adoption Assistance
• Paid Holidays, On-Site Childcare, Café, Fitness Center

Our culture:

• Work-life balance, onsite/hybrid/field work options
• Volunteer and donation programs, Employee Resource Groups
• Training and development, Educational Assistance

Position pays between $128,775 and $180,285 annually, plus potential bonuses, based on experience, location, and qualifications.