About the job
At Precision for Medicine, we redefine what a Contract Research Organization (CRO) can achieve. Leveraging innovative technologies, deep scientific expertise, and operational excellence, we empower the life sciences sector to accelerate the development of groundbreaking therapies that transform patient lives. Our unique approach seamlessly integrates clinical trial execution with advanced data science and laboratory capabilities.
As we expand our footprint in the Asia Pacific region, we are excited to invite a dedicated Senior Clinical Data Manager to join our dynamic team.
Position Overview:
The Senior Clinical Data Manager oversees the comprehensive data management process for clinical trials, from the initiation phase through to post-database lock for assigned projects. This role requires strict adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific documentation while also overseeing database development and testing.
Key Responsibilities Include:
• Serving as the primary Data Management (DM) contact and lead for assigned clinical projects, ensuring continuity and timely task execution. Support may include assisting other Lead DMs as needed.
• Managing the data entry process, which encompasses developing guidelines, providing training, ensuring data quality, and effectively resourcing.
• Conducting quality control checks on data entry and ensuring compliance with clinical data management timelines.
• Creating Case Report Form (CRF) specifications from clinical study protocols and coordinating feedback from relevant stakeholders.
• Assisting in the construction of clinical databases and overseeing User Acceptance Testing (UAT) for database builds, ensuring high-quality documentation.
• Specifying requirements for various edit check types and overseeing their development.
• Maintaining comprehensive data management documentation for the Trial Master File and training clinical research personnel on relevant project aspects.
• Reviewing clinical trial data in accordance with the Data Management Plan and conducting line listing reviews as directed.

