Senior / Clinical Trial Manager (Medical Monitoring)
Viking Therapeutics, Inc.
August 24, 2026
Remote friendly (San Diego, CA)
United States
$120,000 - $150,000 USD yearly
Clinical Research and Development
Sr./Clinical Trials Manager (CTM)
Responsibilities:
- Manage trial operational plans and CRO activities, including project timelines, quality deliverables, and approved trial budgets.
- Support clinical trial management from initiation through close-out.
- Ensure enrollment and data collection meet trial timelines/objectives; escalate risks to timelines and budget as needed.
- Identify clinical trial issues/risks and provide solutions; proactively resolve risks with some supervision.
- Represent Clinical Operations in cross-functional initiatives; act on behalf of team when designated.
- Serve as a liaison/resource for investigational sites.
- Assist with RFPs and bid templates to select CROs/vendors.
- Support CRO selection: review proposals and CRO SOPs; prepare and recommend CRO to management.
- Participate in selection of trial vendors and investigational sites.
- Oversee site adherence to regulations via monitoring reports, CQA-GCP audit reports, Trial Management Files, and communications with sites/CRAs.
- Coordinate CRF/trial materials design and content, including EDC/specification and UAT.
- Contribute to trial documentation (protocols, statistical analysis plans, clinical trial reports, operational plans such as CMP/DMP).
- Review/refine clinical operational plans including monitoring plan and other study plans.
- Participate in Site Initiation Visits and co-monitoring visits per protocol and GCP.
Requirements:
- Bachelor’s Degree.
- CTM: minimum 6 years; Sr. CTM: minimum 9 years relevant clinical trial experience in pharma/biotech.
Skills/Knowledge:
- Track record managing clinical trials from Phase 1 to Phase 3.
- Strong knowledge of FDA, ICH, GCP, CFR, and regulatory requirements.
- Experience with site selection, trial initiation, clinical monitoring, site-to-data flow, and drug safety/regulatory issues.
- Experience negotiating vendor/site contracts and managing budgets; strong vendor management.
- Ability to develop/maintain SOPs and handle multiple tasks to meet deadlines.
- Ability to edit technical documents and informed consent; proficiency with Microsoft Office and Microsoft Project.
- Ability to train personnel; travel 10–15%.
Responsibilities:
- Manage trial operational plans and CRO activities, including project timelines, quality deliverables, and approved trial budgets.
- Support clinical trial management from initiation through close-out.
- Ensure enrollment and data collection meet trial timelines/objectives; escalate risks to timelines and budget as needed.
- Identify clinical trial issues/risks and provide solutions; proactively resolve risks with some supervision.
- Represent Clinical Operations in cross-functional initiatives; act on behalf of team when designated.
- Serve as a liaison/resource for investigational sites.
- Assist with RFPs and bid templates to select CROs/vendors.
- Support CRO selection: review proposals and CRO SOPs; prepare and recommend CRO to management.
- Participate in selection of trial vendors and investigational sites.
- Oversee site adherence to regulations via monitoring reports, CQA-GCP audit reports, Trial Management Files, and communications with sites/CRAs.
- Coordinate CRF/trial materials design and content, including EDC/specification and UAT.
- Contribute to trial documentation (protocols, statistical analysis plans, clinical trial reports, operational plans such as CMP/DMP).
- Review/refine clinical operational plans including monitoring plan and other study plans.
- Participate in Site Initiation Visits and co-monitoring visits per protocol and GCP.
Requirements:
- Bachelor’s Degree.
- CTM: minimum 6 years; Sr. CTM: minimum 9 years relevant clinical trial experience in pharma/biotech.
Skills/Knowledge:
- Track record managing clinical trials from Phase 1 to Phase 3.
- Strong knowledge of FDA, ICH, GCP, CFR, and regulatory requirements.
- Experience with site selection, trial initiation, clinical monitoring, site-to-data flow, and drug safety/regulatory issues.
- Experience negotiating vendor/site contracts and managing budgets; strong vendor management.
- Ability to develop/maintain SOPs and handle multiple tasks to meet deadlines.
- Ability to edit technical documents and informed consent; proficiency with Microsoft Office and Microsoft Project.
- Ability to train personnel; travel 10–15%.