Senior Clinical Trial Lead (Phase I–III)

Regulatory Jobs; San Diego (CA); Vor Ort; USD 150.000 - 180.000; Vollzeit

Zusammenfassung

Viking Therapeutics, Inc. seeks a Senior Clinical Trial Manager to oversee trials from initiation to close-out, ensuring GCP compliance, protocol adherence, and regulatory alignment. You will coordinate CROs, sites, data collection, and vendor contracts while guiding cross-functional teams in a fast-paced environment.

The role requires extensive experience in clinical trial operations, strong communication skills, and the ability to manage multiple trials and stakeholders globally.

Qualifikationen

• Bachelor’s Degree in a relevant field.
• Minimum 9 years of clinical trial experience in pharma/biotech.
• Strong knowledge of FDA, ICH, GCP, CFR guidelines.
• Experience with CROs and budget management.
• Ability to travel 10-15%.

Aufgaben

• Manages trial operational plan and CRO activities, including project timelines & quality of deliverables, and managing approved trial budget(s) throughout the life of the assigned clinical trial(s).
• Supports all aspects of clinical trial management and processes from initiation, planning, execution, maintenance and close-out.
• Ensure enrollment and data collection are completed in accordance with trial timelines and objectives; escalates risk to timelines and budget as needed.
• Identifies and provides solutions to clinical trial issues and/or risks.
• Proactively identifies project risks and resolves with some supervision.
• Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team when designated.
• Serve as a liaison and resource for investigational sites.
• Assists with preparation of RFP's and bid templates to facilitate selection of the CRO's/vendors.
• CRO Selection: Assist with review of proposals from CROs, review CROs’ SOPs, prepare and recommend CRO to management.
• Participates in the selection of trial vendors for assigned trials.
• Maintains frequent and meaningful contact with CROs to assess performance and provide guidance as needed.
• Oversee clinical trial sites' adherence to pertinent regulations through review of monitoring reports, CQA-GCP audit report, Trial Management Files, communications with investigators, trial site personnel, CRAs, and other CRO/designee personnel.
• Coordinate the design, format and content of CRFs, trial guides, trial reference binders, patient diaries, and forms including participating in the EDC and specification process and UAT.
• Contributes to relevant trial documentation including clinical protocols, statistical analysis plan, clinical trial reports as well as operational plans (CMP, DMP).
• Reviews and refines clinical operational plans including the trial monitoring plan and other study plans as needed.
• Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials.
• Participates in the selection of investigational sites with input from Clinical Research and vendors.
• Identify potential trial issues and recommend and implement solutions or corrective actions as needed.
• Participate in Site Initiation Visits and Co-monitoring Visits for adherence to protocol and GCP as required.
• Performs other duties as required.

Kenntnisse

Clinical trial management

Vendor management

Budget management

GCP knowledge

Cross-functional collaboration

Ausbildung

Bachelor's Degree

9+ years clinical trial experience

Tools

Microsoft Project

Microsoft Office

Jobbeschreibung

Viking Therapeutics, Inc. seeks a Senior Clinical Trial Manager to oversee trials from initiation to close-out, ensuring GCP compliance, protocol adherence, and regulatory alignment. You will coordinate CROs, sites, data collection, and vendor contracts while guiding cross-functional teams in a fast-paced environment.

The role requires extensive experience in clinical trial operations, strong communication skills, and the ability to manage multiple trials and stakeholders globally.