Process Engineer Medical Device Jobs in Alaska (NOW HIRING)

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: https://www.olympusamerica.com/careers . 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 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. 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 validationAbility 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. 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 Center Valley, PA and Westborough, MA Are you ready to be a part of our team? Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks . The anticipated base pay range for this full-time position working at this location is $117,068.00 - $163,896.00 / 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 are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply. 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 || Research and Development #J-18808-Ljbffr