Clinical Trial Manager (CTM)

Responsibilities

• Responsible for the implementation and quality execution of assigned clinical protocols according to Corcept SOPs, ICH/GCP, and corporate and department program goals
• Serves as a Study Lead to the multifunctional team to ensure clinical study/studies activities, including study start-up, enrollment, maintenance, and closeout, are executed per timelines and budget
• Oversees aspects of study management and vendors to ensure high quality of data
• Provides Clinical Research Associates with project-specific training, guidance, and oversight, assigning deliverables and having regular meetings with them
• Develops clinical trial protocol synopsis, protocols, amendments as directed by the Clinical Development team and while working with Medical Writing
• Develops critical study documents such as informed consent form templates, site management, and monitoring tools
• Evaluates study designs from an operations perspective, and considers site implementation tactics to suggest feasible solutions and contribute to overall program design and execution
• Develops study timelines and budgets per the corporate and departmental goals and continuously strives to ensure timelines and deliverables are met within budget
• Facilitates the CRO/Vendor selection process for outsourced activities, including developing an RFP, managing the bidding process, analysis of proposals, budgets, and leading and documenting vendor selection decisions. Includes review of Scope of Work, budgets, and negotiating contracts through execution
• Escalates concerns regarding timelines, milestones, resourcing, and any potential study execution issues to appropriate internal stakeholders
• Creates a process for developing distribution, reviews, and tracking essential trial documents and/or oversees CRO or CRA responsibility for essential documents
• Collaborates with team CRAs to ensure essential trial documents are provided to Regulatory for submission to the FDA and other regulatory agencies for IND Updates and Amendments
• Develops and ensures compliance with clinical monitoring plan; conducts or oversees co-monitor as needed for staff training and quality assurance (QA) purposes
• Conducts and/or attends PSVs, SIVs, IMVs, and COVs
• Partners in the development of the case report form (CRF) design process including content, form layout, and edit check review
• Liaison with chemistry, manufacturing, and controls (CMC) team to forecast and monitor overall drug supply and expiration to ensure adequate availability throughout the trial
• Ensures CRA(s) maintain a complete and updated regulatory file for each assigned site
• Manages oversight of Investigational Product (IP) accountability and ensures adequate site supply
• Manages safety reporting to sites and regulatory agencies
• Procures and manages contracts with CROs, study vendors, and investigative sites
• Manages and/or provides oversight of CROs, independent field monitors, and other clinical vendors
• Ensures monitoring trip reports are reviewed and track resolution of all action items on time, per the Monitoring Plan or Corcept SOPs
• Co-monitors at investigative sites to evaluate study site and field monitor performance
• Manages, either directly or through supervised delegation, other study-wide activities such as external vendors, sample handling, drug re-supply, investigator payments, overall data quality, and overall central records quality
• Serves as in-house contact for protocol-related process questions and tracks questions/processes for best practices and consistency
• May help audits clinical data reports for accuracy, safety, and/or efficacy trends; as necessary prepare related presentations
• Exercises sound judgment to resolve or, as appropriate seek expert input on protocol and drug questions, safety, regulatory, and legal questions. Ensures resolution is tracked and consistently messaged to all team members and clinical sites
• Contributes to the SOP review process and other Clinical Operations Initiatives, as necessary
• Demonstrates excellent knowledge of ICH guidelines, FDA regulations, and company SOPs related to clinical studies and coach junior staff on the same
• Ensures Trial Master File is maintained throughout the study
• P Practices professionalism and integrity in all actions and relationships with Corcept management, supervisors, team members, direct reports, and vendors. Exhibits and models leadership behavior through communication and appropriate temperament. Ability to have difficult/crucial conversations with tact. Demonstrates ability to foster teamwork, cooperation, self-mastery, and flexibility to get the work done. Maintains composure under difficult circumstances

Qualifications

• Relevant BS / BA degree or nursing degree
• 6+ years’ experience as a CRA or field monitor in a biotech, pharmaceutical, or CRO company
• Study-related management experience