Job Description

Job Description

Job Description

Contact: Neisha Camacho/Terra Parsons -
No 3rd party agencies

We are seeking a dynamic and innovative Senior Clinical Data Manager with a proven ability to manage the full scope of clinical trial data management, from study start-up through post-database lock. This role is ideal for a professional who thrives in a small biotech environment, where wearing multiple hats and working independently is the norm. The ideal candidate will bring fresh perspectives to traditional processes, offering creative solutions to enhance efficiency and effectiveness. We are looking for someone who is agile, highly knowledgeable, confident in their expertise, and capable of providing well-reasoned, professional insights.

This is a unique opportunity to bring your expertise, fresh perspective, and leadership skills to a small, agile team making a significant impact in clinical data management.

Responsibilities :

• Serve as the primary Data Management contact and contributor for assigned clinical projects, ensuring seamless continuity, responsiveness, and timely task completion.
• Manage end-to-end data management activities, including developing CRF specifications, coordinating stakeholder feedback, and ensuring data quality.
• Lead database build UAT, maintain quality-controlled documentation, and specify requirements for all types of edit checks (e.g., electronic, manual data review).
• Oversee QC and UAT of EDC systems and modules, including database and data export testing.
• Coordinate with vendors to ensure efficient and high-quality electronic data receipt, integration, and reconciliation.
• Address and troubleshoot technical issues independently and efficiently.
• Perform SAE/AE reconciliation and oversee pre-lock and database lock activities.
• Collaborate effectively in vendor and internal meetings, providing status updates and recommending best practices.

Requirements :

• Bachelor’s degree in a clinical or scientific discipline with 9+ years of direct clinical data management experience in pharmaceutical, academic, or CRO settings.
• Demonstrated ability to work independently in a fast-paced environment with minimal supervision.
• Expertise in EDC systems such as Medidata Rave, InForm, or Medrio.
• Strong track record of hands-on clinical data management experience, including leadership capabilities and strategic thinking.
• Proficiency in CDISC/SDTM standards and familiarity with SAS, SQL, or other programming tools.
• In-depth understanding of clinical data coding systems (e.g., MedDRA, WHO-Drug) and Good Clinical Data Management Practices.
• Exceptional organizational, time management, and communication skills.
• Ability to critically evaluate and rethink traditional processes, implementing innovative and effective solutions.
• Collaborative and confident, with the ability to liaise across all levels of the organization and external partners, etc.

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