Manager Clinical Data Management

Redbock - an NES Fircroft company; Redwood City (CA); Sur place; USD 140 000 - 210 000; Plein temps

Résumé du poste

Redbock - an NES Fircroft company in Redwood City, CA, seeks a Senior Clinical Data Manager to lead CDM activities for early- to late-stage studies. You will oversee data standards, CRFs, EDC, and DM plans, and mentor junior staff.

Strong regulatory knowledge and cross-functional collaboration are essential. This role requires 11+ years in clinical trials, an MS or BS in a relevant field, and extensive experience with databases, ICH, FDA and GCP guidelines.

Qualifications

• 11+ years of experience designing and running early- or late-stage clinical trials.
• Proven knowledge of clinical databases, standards, medical terminology, and quality control/audit processes.
• Strong working knowledge of ICH, FDA, and GCP regulations and guidelines.

Responsabilités

• Plans, coordinates, and manages CDM tasks for clinical studies.
• Acts as liaison with CROs and third-party data vendors.
• Reviews protocols and CRFs; authors CRF completion guidelines.
• Oversees EDC database development, testing, maintenance, and lock/unlock.
• Ensures compliance with Data Management Plans throughout studies.
• Sets and manages Data Management project timelines and status updates.
• Addresses data issues; manages external vendor documentation and reconciliation.
• Leads data listings, summaries, and data transfer prep for statistical review and audits.
• Mentors internal data management staff and leads SOP development.

Connaissances

Clinical Data Management

Cross-functional coordination

Regulatory knowledge

Formation

MS/BS in a relevant field

Outils

EDC systems

Data standards

Description du poste

• Recent small to midsized pharma/biotech experience required – no recent CRO experience)
• Long term experience at most roles (2+ years)

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 case report forms (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.

Required

• MS, BS/BA degree, or other suitable qualification with relevance to the field.
• 11 or more years' direct experience of designing and running early-stage or late-stage clinical trials.
• Knowledge of, and experience with, 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.