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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

data managementclinical data managementdata integrityrisk mitigationdata quality strategiesfull-cycle data managementFDA regulationsICH-GCPGCDMPMedDRA

Soft Skills

leadershipstakeholder managementcross-cultural sensitivityglobal collaborationanalytical skillsorganizational skillscommunication skillsinterpersonal skillsability to manage multiple prioritiesvendor management