Senior Clinical Data Manager
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Job Description
Senior Clinical Data Manager overseeing data management deliverables for clinical trials at Olympus. Collaborating with cross-functional teams ensuring data quality and compliance with industry standards.
Responsibilities:
- Accountable for driving timely and high-quality data management deliverables supporting the Olympus portfolio
- 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
- Accountable for quality study dataset release and consistency for submission data
- Serves as a key liaison between clinical operations, biostatistics, and external vendor
- Responsible for leading data management responsibilities for several concurrent clinical trials
- Utilizes the electronic data capture and management systems
- Manages trials in various stages, from planning, to start-up, conduct, closeout, and archiving
- Assists in the design and implementation of clinical data management processes with vendors
- Ensures completeness, correctness, and consistency according to Siemens standards
- Collaborates with the Biostatistics and Clinical Operations team members, and other functions as applicable
Requirements:
- 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 (Specifically, Medidata Rave)
- Proven leadership in managing full-cycle data management activities
- Experience with risk mitigation and data quality strategies
- 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
- Excellent verbal and written communication skills and interpersonal skills
- 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
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
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