Olympus Corporation · 4 hours ago
Senior Clinical Data Manager
Center Valley, PA
Full-time
Hybrid
Mid, Senior Level
$117K/yr - $164K/yr
6+ years expOlympus Corporation is a global medical technology company focused on improving patient outcomes. The Senior Clinical Data Manager will oversee data management activities for clinical trials, ensuring the integrity and accuracy of clinical data in compliance with regulatory standards and leading data management responsibilities across multiple studies.
ElectronicsIndustrialManufacturingMedical DeviceProduct Design
Responsibilities
Work collaboratively with other Data Managers, Programmers, Biostatisticians, Clinical Operations, Medical Directors, and Regulatory staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
Focus on study-start up and database amendment implementation
Study level coordination and hands-on CDM tasks, including clinical data review and reconciliation
Authors data management plans (DMP), case report forms (CRFs), edit check specifications, and data validation rules
Manage database design, build, testing, and validation activities with internal teams or CROs/vendors
Provide oversight of external DM and data vendors to deliver high quality data management for all assigned studies
Oversee data cleaning activities including query generation/resolution, data reconciliation (e.g., SAE, lab, coding), and data reviews
Conduct ongoing risk-based data reviews to ensure data quality and identify trends or issues early
Collaborate with cross-functional teams (Clinical Ops, Safety, Biostatistics, Programming, Regulatory)
Manage timelines and deliverables for database locks (interim and final), ensuring audit readiness
Coordinate with EDC and other data vendors (e.g., ePRO, IRT, central labs), ensuring seamless integration and data flow
Represent data management in study team meetings and regulatory audits or inspections
Ensure completeness, correctness and consistency of clinical data and data structure across projects
Ensure accurate tracking and reporting of study metrics and timelines
Proactively drives quality and efficiency to meet timelines and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team(s)
Assist with support of regulatory submission activities for assigned projects
Communication and escalation of study level issues including processes, timelines, resourcing, performance, etc
Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements as applicable
Assist in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM
Support development and maintenance of CDM SOPs and training materials
Mentor and train junior data managers or contractors as needed
Other duties as assigned
Qualification
Required
BS degree in a Biomedical Science or comparable field of study
Bachelor's degree with a minimum of 8 years of global clinical data management experience, or a Master's degree with a minimum of 6 years of experience
Prior experience in a sponsor, CRO, or medical device company. In-depth knowledge and experience with FDA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide coding dictionaries such as MedDRA
Strong expertise in implementing and maintaining systems for global trials (e.g., Medidata Rave, Oracle InForm, Veeva)
Proven leadership in managing full-cycle data management activities
In-depth knowledge of ICH-GCP, FDA/EMA regulations, and GCDMP
Strong expertise in implementing and maintaining systems for global medical device trials (Class II/III or combination products)
Excellent stakeholder management skills with cross-cultural sensitivity and global collaboration experience
Strong experience in vendor management and system validation
Ability to collaborate effectively with the study team, cross-functional team members and external partners
Excellent verbal and written communication skills and interpersonal skills are required
Excellent analytical, organizational, and communication skills
Ability to manage multiple priorities in a fast-paced environment
Proficiency with clinical data systems and MS Office Suite
Position may require some travel
Candidates must be authorized to work in the U.S
Occasional meetings out of normal working hours will be required as this role supports a global team (EMEA, Japan, China, APAC)
Preferred
Experience with CDASH/SDTM standards preferred
Experience supporting PMA, IDE, or 510(k) submissions preferred
Benefits
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
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
Company
Olympus Corporation
Olympus is passionate about creating customer-driven solutions for the medical industry.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Yasuo Takeuchi
Executive Chairman
Recent News
2025-05-27
2025-05-19
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