Senior Clinical Trial Manager (Sr CTM)
Corcept Therapeutics
August 20, 2026
Remote friendly (Redwood City, CA)
United States
$170,500 - $200,700 USD yearly
Clinical Research and Development
Responsibilities:
- Identify workflow/documentation gaps and design scalable, inspection-ready SOPs/processes for high-quality study execution.
- Author and continuously improve SOPs, work instructions, templates, and forms aligned with ICH-GCP E6 (R2/R3).
- Assess downstream impact of SOP/process changes on ongoing trials, vendor contracts, and clinical systems (e.g., CTMS).
- Facilitate cross-functional SOP review/working groups; contribute to SOP governance, inspection readiness, and continuous improvement.
- Execute assigned clinical protocol per Corcept SOPs, ICH/GCP, and program goals.
- Serve as study lead for start-up, enrollment, maintenance, and close-out within timeline and budget.
- Support Clinical Development/Medical Writing on protocol synopsis, protocols, and amendments.
- Facilitate CRO/vendor selection (RFP, bidding, proposal analysis, budgets, vendor decision documentation) and negotiate/manage contracts.
- Procure/manage contracts with CROs, vendors, and investigative sites.
- Develop key study documents (e.g., informed consent form templates, management plans, trackers), timelines, budgets, and trial document distribution/oversight.
- Provide site essential regulatory documents to Regulatory for FDA/other agency submissions.
- Oversee CROs/monitors/vendors; ensure resolution of action items/protocol deviations.
- Manage study-wide activities (vendors, sample handling, drug re-supply, investigator payments, data quality, central records).
- Audit clinical data reports for accuracy/safety/efficacy trends; prepare related presentations.
- Ensure Trial Master File maintenance.
Preferred Education and Experience:
- Relevant BS/BA or nursing degree.
- 8+ years in biotech/pharma leading cross-functional clinical activities.
- Management experience, including outsourcing to CROs.
Preferred Skills/Qualifications:
- Knowledge of US regulations and GCP/ICH.
- Clinical trials process/SOP application and medical terminology.
- Ability to read scientific literature.
- Strong Microsoft Office and computer application proficiency.
Application Instructions:
- Must be currently authorized to work in the United States on a full-time basis.
Pay range (headquarters-based): $170,500–$200,700.
- Identify workflow/documentation gaps and design scalable, inspection-ready SOPs/processes for high-quality study execution.
- Author and continuously improve SOPs, work instructions, templates, and forms aligned with ICH-GCP E6 (R2/R3).
- Assess downstream impact of SOP/process changes on ongoing trials, vendor contracts, and clinical systems (e.g., CTMS).
- Facilitate cross-functional SOP review/working groups; contribute to SOP governance, inspection readiness, and continuous improvement.
- Execute assigned clinical protocol per Corcept SOPs, ICH/GCP, and program goals.
- Serve as study lead for start-up, enrollment, maintenance, and close-out within timeline and budget.
- Support Clinical Development/Medical Writing on protocol synopsis, protocols, and amendments.
- Facilitate CRO/vendor selection (RFP, bidding, proposal analysis, budgets, vendor decision documentation) and negotiate/manage contracts.
- Procure/manage contracts with CROs, vendors, and investigative sites.
- Develop key study documents (e.g., informed consent form templates, management plans, trackers), timelines, budgets, and trial document distribution/oversight.
- Provide site essential regulatory documents to Regulatory for FDA/other agency submissions.
- Oversee CROs/monitors/vendors; ensure resolution of action items/protocol deviations.
- Manage study-wide activities (vendors, sample handling, drug re-supply, investigator payments, data quality, central records).
- Audit clinical data reports for accuracy/safety/efficacy trends; prepare related presentations.
- Ensure Trial Master File maintenance.
Preferred Education and Experience:
- Relevant BS/BA or nursing degree.
- 8+ years in biotech/pharma leading cross-functional clinical activities.
- Management experience, including outsourcing to CROs.
Preferred Skills/Qualifications:
- Knowledge of US regulations and GCP/ICH.
- Clinical trials process/SOP application and medical terminology.
- Ability to read scientific literature.
- Strong Microsoft Office and computer application proficiency.
Application Instructions:
- Must be currently authorized to work in the United States on a full-time basis.
Pay range (headquarters-based): $170,500–$200,700.