Clinical Trial Manager (CTM)

Corcept Therapeutics•Redwood City, CA

10h•Hybrid

About The Position

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. The Clinical Trial Manager (CTM) will independently manage all clinical aspects of a medium to large clinical study or up to two smaller clinical studies. This role will work closely with cross-functional teams, vendors, sites, and CRO (when applicable) to ensure compliance with protocol and the overall clinical objective. Additionally, this role will be responsible for implementing and monitoring clinical study activities to assure adherence to good clinical practices (GCPs), standard operating procedures (SOPs), and study protocols. This is a hybrid role that typically requires on-site presence three days per week.

Requirements

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
Attention to detail and ability to prioritize tasks to meet critical deadlines
Excellent verbal and written communication
Able to collaborate effectively with the study team, cross-functional team members, and external partners
Knowledge of US and GCP/ICH regulations
Understanding of the clinical trials process, the application of SOPs, and medical terminology
Strong interpersonal, problem-solving, and organizational skills
Self-motivated and able to motivate others
Sound judgment and discretion
Attention to detail and ability to prioritize tasks to meet critical deadlines
Ability to read and understand scientific literature
Strong organization and time management skills
Ability to develop and deliver compelling and concise presentations
Able to work effectively on project teams and independently
Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools
Applicants must be currently authorized to work in the United States on a full-time basis.

Responsibilities

Responsible for the implementation and quality execution of assigned clinical protocols according to Corcept SOPs, ICH/GCP, and corporate and department program goals
May serve 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
Providing 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
Responsible for tracking and managing study execution to resources and goals
Facilitating 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 issue 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
May conduct and/or attend 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
Contribute 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
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
Travel may be up to 30% occasionally
This position may supervise the following positions: Clinical Operations Consultants and Clinical Research Associates