Clinical Trial Manager (CTM)

Responsibilities:
- Independently manage clinical aspects of medium to large studies (or up to two smaller studies), ensuring compliance with protocol, GCP/ICH, and Corcept SOPs.
- Serve as Study Lead; oversee start-up, enrollment, maintenance, and closeout per timelines and budget.
- Oversee study management/vendors to ensure high-quality data.
- Provide CRA training/guidance/oversight; assign deliverables and hold regular meetings.
- Develop protocol synopsis, protocols, and amendments with Medical Writing.
- Create key study documents (e.g., informed consent form templates, site management/monitoring tools).
- Develop feasible study designs, timelines, and budgets; track execution against resources/goals.
- Lead outsourced activity vendor/CRO selection (RFP, bidding, proposal analysis, budgets, negotiations/contracts).
- Escalate risks/issues related to timelines, milestones, and resourcing.
- Maintain essential trial document distribution/review processes (or oversee CRO/CRA responsibility).
- Coordinate essential documents for regulatory submission (IND updates/amendments).
- Ensure clinical monitoring plan compliance; conduct/oversee co-monitoring for QA/training.
- Participate in PSVs/SIVs/IMVs/COVs as needed.
- Partner in CRF design (content/layout/edit checks).
- Liaise with CMC to forecast/monitor drug supply/expiration.
- Ensure updated regulatory files, IP accountability, site supply, and safety reporting.
- Manage oversight of CROs/monitors and ensure timely review of monitoring trip reports/action item resolution.
- Co-monitor sites; manage study-wide activities (vendors, sample handling, re-supply, payments, data/central records quality).
- Act as protocol process contact; resolve protocol/drug/safety/regulatory/legal questions; support SOP/process initiatives and audits as needed.
- Ensure Trial Master File maintenance; uphold professionalism/integrity. Travel up to 30% occasionally. May supervise Clinical Operations Consultants and Clinical Research Associates.

Preferred Education and Experience:
- BS/BA (relevant) or nursing degree.
- 6+ years as a CRA/field monitor in biotech/pharma/CRO; study-related management experience.

Preferred Skills/Qualifications:
- Attention to detail; prioritize to meet deadlines.
- Strong verbal/written communication; collaboration across functions and partners.
- US GCP/ICH knowledge; understanding clinical trials/SOPs/medical terminology.
- Problem-solving, organizational, interpersonal skills; self-motivated.
- Ability to read scientific literature; deliver presentations.
- Strong Microsoft Office and computer/tool proficiency.

Application instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.