Senior Clinical Data Manager at cGxPServe San Francisco, CA

Comunidade Metodista; San Francisco (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

cGxPServe is seeking a Senior Clinical Data Manager in San Francisco, CA. You will lead data management across studies, ensure secure data sharing, and supervise data teams to meet study timelines.

You will coordinate with Sponsors and KPS, maintain database integrity, and ensure compliance with ICH GCP and SOPs, while mentoring junior staff and driving data quality improvements.

Qualifications

• BS/BA or Master’s degree in a biological, analytical/data, health-related, or CS field.
• 7-10 years of experience in a pharmaceutical or CRO setting.
• 5 years of experience in Data Management.
• Knowledge of EDC solutions such as Oracle Clinical, Medidata RAVE or Inform.
• Experience with insourced and CRO-outsourced studies.
• Proficient with Microsoft Office; strong data literacy.
• Strong management and motivation skills.
• Ability to manage study teams and escalations to meet DB cleaning/lock timelines.
• Extensive knowledge of ICH GCP guidelines.
• Excellent interpersonal, written, and oral communication skills.

Responsibilities

• Participate in clinical meetings with Sponsor and KPS personnel as required.
• Ensure data management deliverables are met.
• Establish rules and procedures for secure data sharing with executives.
• Manage data management resourcing for all clinical studies.
• Prepare documents and ensure tools are arranged for data capture and cleaning.
• Ensure delivery of a clean and secure database.
• Instruct, communicate, coach and mentor others on data management procedures.
• Ensure compliance with ICH GCP and sponsor SOPs.

Skills

Data management

Clinical data management

Leadership

Communication

Education

BS/BA or Master’s in a relevant field

Tools

EDC systems (Oracle Clinical, Medidata RAVE, Inform)

Job description

Senior Clinical Data Manager job at cGxPServe. San Francisco, CA.

Responsibilities:

• Participate in clinical meetings with Sponsor and KPS personnel as required.
• Take necessary actions to ensure data management deliverables are met.
• Establish rules and procedures for secure and responsible data sharing with executives.
• Manage data management resourcing for all clinical studies, as required.
• Prepare documents and ensure tools are arranged to allow for data capture and data cleaning.
• Ensure delivery of a clean and secure database.
• Instruct, communicate, coach and mentor others on data management procedures.
• Ensure compliance with EMEA, FDA, and ICH GCP regulations and policies.
• Ensure compliance with appropriate Sponsor SOPs.

Requirements:

• BS/BA or master's degree with preference in a biological, analytical/data, health related, or computer science field.
• 7-10 years related experience in a pharmaceutical or CRO setting.
• 5 years' experience in Data Management.
• Knowledge of EDC solutions (Oracle Clinical, Medidata RAVE, Inform, etc.).
• Experience working on studies both insourced or outsourced to a CRO.
• Current computer literacy in appropriate software (i.e. Current with recent versions of Microsoft Office software suite).
• Strong management and motivation skills.
• Ability to manage study teams and perform issue escalation to meet database cleaning and lock timelines.
• Extensive and comprehensive knowledge of international ICH GCP guidelines.
• Excellent interpersonal, written, and oral communication skills.