Director, Clinical Data Management

Planet Pharma; Redwood City (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Planet Pharma is seeking an Associate Director of Clinical Data Management to lead CDM activities across trials and collaborate with functional leaders to ensure data integrity and timely delivery.

Responsibilities include managing CDM tasks, reviewing CRFs, overseeing EDC systems, and ensuring adherence to Data Management Plans while mentoring internal staff. Industry experience and strong regulatory knowledge are essential.

Qualifications

• MS, BS/BA degree or equivalent in a relevant field.
• 11+ years’ direct experience designing and running early-stage or late-stage clinical trials.
• Knowledge of clinical databases, standards, medical terminology, medical coding dictionaries, quality control processes, and auditing procedures.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
• A demonstrable record of strong leadership and teamwork.
• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies.
• Excellent written and verbal communication skills.
• Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important.
• Experience from industry is essential.

Responsibilities

• Plans, coordinates, and manages CDM tasks for clinical studies.
• Participate and review CRO proposals.
• Acts as primary liaison with CROs, third party data vendors, EDC vendors.
• Reviews clinical protocols and cross functional plans.
• Serves as primary reviewer or author of CRFs and CRF completion guidelines.
• Oversees and participates in all aspects of EDC database development, testing, maintenance, and lock/unlock.
• Ensures Data Management Plans are followed through the course of the studies.
• Sets and manages Data Management project timelines.
• Provides comprehensive status updates to project team members.
• Address data issues identified by cross-functional team members, accountable for external data vendor documentation, management, and reconciliation.
• Assist in defining and creating data listings, summary table validation, data specifications, and process data transfers in preparation for statistical review and data management audit.
• Implements data standardization and maintains data model across projects.
• Direct management and mentoring responsibilities for internal data management team members.
• Lead department initiatives e.g., development of SOPs.
• Other duties as assigned.

Skills

Leadership

Teamwork

Communication

Multi-tasking

Prioritization

Regulatory knowledge

Industry experience

Education

MS/BS degree

Job description

Planet Pharma is seeking an Associate Director of Clinical Data Management to lead CDM activities across trials and collaborate with functional leaders to ensure data integrity and timely delivery.

Responsibilities include managing CDM tasks, reviewing CRFs, overseeing EDC systems, and ensuring adherence to Data Management Plans while mentoring internal staff. Industry experience and strong regulatory knowledge are essential.