Job Description

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 As part of the Medical and Scientific Affairs group, an integral delivery unit within the Global Clinical Affairs organization, the Sr. Clinical Data Manager is accountable for driving timely and high-quality data management deliverables supporting the Olympus portfolio. The Sr. Clinical Data Manager designs, develops, and maintains key data management deliverables used to collect, review, monitor, and ensure integrity of clinical data, oversees application of industry standards, data review and query management, and is accountable for quality study dataset release and consistency for submission data. This role is responsible for overseeing the planning, execution, and delivery of data management activities for complex or pivotal global clinical trials. This role ensures the integrity, accuracy, and completeness of clinical trial data in compliance with regulatory standards, SOPs, and Good Clinical Data Management Practices (GCDMP). This position serves as a key liaison between clinical operations, biostatistics, and external vendor and is responsible for leading data management responsibilities for several concurrent clinical trials, utilizing the electronic data capture and management systems. This role manages trials in various stages, from planning, to start-up, conduct, closeout, and archiving. The role assists in the design and implementation of clinical data management processes with vendors, ensuring completeness, correctness, and consistency according to Siemens standards. This role collaborates with the Biostatistics and Clinical Operations team members, and other functions as applicable. Job Duties 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 function 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. Job Qualifications 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. The anticipated base pay range for this full‑time position working at this location is $117,068.00–$163,896.00 per 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. 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). Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Research and Development 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, age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), 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. #J-18808-Ljbffr Olympus Corporation of the Americas

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