Director, Data Management and Systems

Req ID: 9776

Working Location: NATIONWIDE

Workplace Flexibility: Field

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

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

This role provides strategic leadership in the design, implementation, and continuous improvement of systems, processes, and procedures supporting data management for medical device clinical studies across North America, Europe, Asia-Pacific, and emerging markets.

This role drives operational efficiency and consistency by establishing best practices, harmonizing data management approaches across programs, and ensuring alignment with global regulatory requirements. This position plays a key role in the design of integrated systems and operational frameworks that enable efficient, scalable clinical trial management across the organization. This individual oversees vendor performance, champions process innovation, and fosters cross-functional collaboration to ensure the delivery of high-quality, reliable clinical data that supports successful study execution and regulatory outcomes.

Job Duties

Lead and oversee data management activities across multiple clinical trials, ensuring coordination of deliverables, compliance with regulatory requirements, and alignment with project timelines and quality standards.
Lead global system strategy development, governance, and change management initiatives across all study phases (pre-market and post-market).
Manage vendor relationships, including oversight of CROs and external data providers, ensuring effective communication, performance, and delivery of data management services in support of clinical operations.
Develop and implement data management strategies, including the creation and maintenance of Data Management Plans, Standard Operating Procedures (SOPs), and Work Instructions to drive consistency, quality, and operational efficiency.
Oversee the global deployment and harmonization of clinical research systems including: CTMS, EDC, eTMF, eCOA, IRT, and device-specific imaging and diagnostics platforms.
Ensure all systems comply with global regulatory standards including:ISO 14155, FDA 21 CFR Part 11, EU MDR, ICH-GCP, GDPR, and local country-specific requirements.
Ensure data integrity and system readiness by reviewing clinical documents and database specifications, supporting user acceptance testing (UAT), managing data reconciliation activities, and validating data outputs for interim and final analyses.
Collaborate cross-functionally and support regulatory readiness, serving as the primary data management contact, contributing to protocol and CRF development, and participating in audits and regulatory inspections as needed.
Collaborate with global and regional Clinical Operations, Regulatory, Quality, Data Management, and IT teams to align workflows and standard operating procedures (SOPs).
Manage system integrations across enterprise platforms (e.g., ERP, QMS, safety systems).
Oversee validation activities and system lifecycle documentation per global computer system validation and audit standards.
Partner with global vendors and CROs to ensure technology delivery meets business and compliance expectations.
Establish KPIs and dashboards to track data quality, system usage, and trial efficiency across regions.
Serve as the global systems lead in internal and external audits/inspections.
Other duties as assigned.

Job Qualifications

Required:

Bachelor’s or Master’s degree in Life Sciences, Information Systems, Biomedical Engineering, or related discipline.
Minimum of 10 years of experience in clinical systems, digital health technology, or clinical operations — with at least 5 years in a leadership role within a global medical device company, is required.
Strong expertise in implementing and maintaining systems for global medical device trials (Class II/III or combination products).
Proven knowledge of international clinical regulations (FDA, EMA, PMDA, NMPA, Health Canada, etc.).
Excellent stakeholder management skills with cross-cultural sensitivity and global collaboration experience.
Strong experience in vendor management, system validation, and IT governance.

Preferred:

Experience with Veeva Vault Clinical Suite, Medidata, MasterControl, or other cloud-based global platforms is preferred.
International work experience is strongly preferred.

Why join Olympus?

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

Equitable Offerings you can count on:

Competitive salaries, annual bonus and 401(k)* with company match
Comprehensive medical, dental, vision coverage effective on start date
24/7 Employee Assistance Program
Free live and on-demand Wellbeing Programs
Generous Paid Vacation and Sick Time
Paid Parental Leave and Adoption Assistance*
12 Paid Holidays
On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

Work-life integrated culture that supports an employee centric mindset
Offers onsite, hybrid and field work environments
Paid volunteering and charitable donation/match programs
Employee Resource Groups
Dedicated Training Resources and Learning & Development Programs
Paid Educational Assistance

*US Only

**Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefit and incentives.

The anticipated base pay range for this full-time position working at this location is $141,361.00 - $212,041.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

You Belong at Olympus

We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs

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