Clinical Data Manager
princeps technologies
- New York, New York, United States
- New York, New York, United States
About
Job Title : Clinical Data Manager – Mid-Level Location : United States or Canada (Remote/Hybrid) Employment Type : Full-Time Position Overview We are seeking a highly skilled and detail-oriented
Clinical Data Manager
with a minimum of 5 years of experience in clinical data management. The ideal candidate will have proven expertise in writing specifications, conducting user acceptance testing (UAT) for listing programs, and performing data review in accordance with a defined Data Review Plan (DRP). This role requires a strong understanding of clinical trial processes, regulatory standards, and technical systems used in data management. Key Responsibilities Develop detailed specifications for clinical data listings and collaborate with programming teams Conduct
User Acceptance Testing (UAT)
to validate the accuracy and compliance of listings Perform comprehensive
data review
activities following the Data Review Plan Ensure data quality and integrity in alignment with clinical protocols and regulatory requirements Support EDC system setup, validation, and maintenance Collaborate effectively with cross-functional teams including Biostatistics, Clinical Operations, and Medical Writing Participate in audit preparedness and contribute to documentation for regulatory submissions Required Qualifications Bachelor's degree in Life Sciences, Pharmacy, or a related discipline Minimum 5 years
of experience in Clinical Data Management within pharmaceutical, CRO, or biotech environments Strong knowledge of
ICH-GCP guidelines
and
FDA 21 CFR Part 11
compliance Proficiency in EDC systems (e.g., Medidata Rave, Oracle InForm), CDMS platforms, and Microsoft Office Demonstrated ability to manage multiple priorities with excellent organizational and time management skills Strong analytical thinking, problem-solving, and project management capabilities Excellent written and verbal communication skills with the ability to collaborate across teams Seniority level
Mid-Senior level Employment type
Full-time Job function
Other, Health Care Provider, and Analyst Industries
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Languages
- English
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