Clinical Data Manager
Posted 22 days ago
You'll complete your application on Innovaderm Research Inc.'s career site.
About the Role
This established contract research organization focuses exclusively on dermatology and has provided clinical trial expertise across Phases I through IV since 2000. With an international footprint in North America and Europe, the firm provides services ranging from regulatory consulting and trial design to project management. The Clinical Data Manager serves a vital function by facilitating data management tasks for sponsors, vendors, and project teams. You will manage the end-to-end clinical data lifecycle, spanning system configuration and upkeep to final archiving, while ensuring all work adheres to internal procedures, regulatory standards, and established deadlines to support successful research initiatives.
Requirements
- You must hold a Bachelor of Science in a relevant discipline, while a Master of Science is viewed as an asset.
- You need 5 to 10 years of professional background in clinical data management within a CRO, biotech, or pharmaceutical setting.
- You must demonstrate advanced proficiency in EDC platforms, database programming, database architecture, and CDISC SDTM/CDASH requirements.
- You should have a comprehensive grasp of drug development cycles, Good Clinical Practices, and both FDA and Health Canada regulations.
- You are required to be proficient in utilizing WHODrug and MedDRA coding dictionaries.
- You must possess excellent English communication skills, strong analytical capabilities, and the ability to balance numerous urgent tasks in a demanding environment.
- You must have legal authorization to perform work within the Philippines.
Responsibilities
- You will draft eCRF specifications, design data capture interfaces, and program edit checks while validating and maintaining clinical databases.
- You will author eCRF completion manuals, facilitate training for site personnel and monitors, and coordinate data transfer agreements with outside vendors.
- You will conduct routine data scrubbing and verification, perform medical coding, and produce progress reports to prepare for database lock.
- You will update Trial Master File documentation, assist EDC users, and supervise external partners to verify that project milestones and protocol standards are achieved.
- You will help develop and revise internal standard operating procedures and provide guidance to Clinical Data Coordinators.
Benefits & Perks
- This is a full-time, permanent role based remotely with a flexible schedule.
- You will receive support for professional development and training, along with opportunities to advance your career.
Note: This listing is summarized and paraphrased by WorkNow from a publicly posted role. For the original wording and full details, please refer to the employer's official posting.
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