Clinical Data Manager — Drive Data Quality & Timeliness

Viking Therapeutics; San Diego (CA); Vor Ort; USD 110.000 - 120.000; Vollzeit

Zusammenfassung

Viking Therapeutics, Inc. is seeking a Clinical Data Manager to ensure timely conduct of data management activities for assigned studies in line with protocols, SOPs and regulatory requirements.

The role involves interacting with cross-functional teams and CROs, with title depending on experience. The position requires experience in data management, CRF design, EDC/IRT/ePRO, and data review plans, as well as strong communication and documentation skills.

Qualifikationen

• : Bachelor's degree or higher in a medical or scientific field.
• : 2+ years of experience in Clinical Data Management; 3+ years in a Clinical Data Manager role preferred.
• : Experience writing plans and technical specifications for Clinical Data Management.
• : Experience in clinical data entry system design, development, and maintenance.
• : Experience carrying out data review plans.
• : Experience managing multiple projects at once.
• : Preferred: Experience in Phase 3 clinical trials.
• : Strong analytical and problem-solving skills; excellent verbal and written communication.

Aufgaben

• Oversee CRO Data Management counterparts for assigned studies
• Provide status updates on Data Management responsibilities to internal team, including metrics and progress on deliverables
• Ensure the development of high-quality study documentation from CROs for clinical trial data collection, handling, processing, quality control, and archival, including Data Management Plans (DMP)
• Facilitate filing of study Data Management documents in the sponsor Trial Master File (TMF)
• Establish optimal design of Case Report Forms (CRF) and CRF Completion Guidelines (CCG) to align with protocol requirements
• Manage the development and maintenance of data entry systems for clinical trials, including EDC, IRT, and ePRO
• Develop data review strategies, processes, and specific checks for assigned studies
• Coordinate timely data transfers including development of Data Transfer Agreements (DTAs)
• Monitor and contribute to data review processes to verify timely data review
• Partner with study team members in managing pre-lock activities and on-time database lock
• Collaborate across functional areas and CROs/vendors
• Identify and communicate risk to Data Management timelines and propose solutions
• Adhere to ICH, GxP, CDISC, 21 CFR Part 11, FDA guidelines
• Other duties as required

Kenntnisse

Data Management

Verbal communication

Written communication

Attention to detail

Analytical skills

Microsoft Office

Ausbildung

Bachelor's degree or higher in a medical or scientific field

Tools

EDC

IRT

ePRO

MS Office Suite

Jobbeschreibung

Viking Therapeutics, Inc. is seeking a Clinical Data Manager to ensure timely conduct of data management activities for assigned studies in line with protocols, SOPs and regulatory requirements.

The role involves interacting with cross-functional teams and CROs, with title depending on experience. The position requires experience in data management, CRF design, EDC/IRT/ePRO, and data review plans, as well as strong communication and documentation skills.