Sr. Clinical Trial Manager

Job Description:

The Senior Clinical Trial Manager (Sr. CTM) will independently manage all operational aspects of up to three clinical studies. This role requires working within a cross functional team, including internal Corcept stakeholders, vendors, clinical sites and CRO(s) (when applicable) to execute the requirements of the protocol and ensure overall study deliverables, milestones and objective(s) are met within defined timelines and budget.  The Sr. CTM will be responsible for implementing, overseeing and monitoring all clinical study activities to assure adherence to good clinical practices (GCPs), standard operating procedures (SOPs), and study protocols.  Direct line management of Clinical Research Associates (CRAs) may be required including mentorship and delegation and oversight of tasks/duties.

Responsibilities:

• Responsible for the implementation and quality execution of assigned clinical protocols according to Corcept SOPs, ICH/GCP and corporate and departmental program goals.
• Serves as a Study Lead to the multifunctional team to ensure clinical study/studies activities including study start-up, enrollment, maintenance and close-out are executed per timeline and budget.
• Oversees aspects of study management for accurate execution of the study to ensure high quality of data.
• May work with Clinical Development and/or Medical Writing to generate clinical trial protocol synopsis, protocols and protocol amendments
• 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.
• Procures and manage contracts with CROs, study vendors and investigative sites.
• Develops critical study documents, including, but not limited to informed consent form templates, various management plans and study trackers. May delegate the development of the documents to CRA(s) but will be ultimately responsible for the quality of the documents.
• Develops study timelines and budgets per the corporate and departmental goals and continuously strive to ensure timelines are deliverables are met within budget.
• Track and manage required resources to ensure study and program goals are met.
• Develops, distributes, reviews and tracks essential trial documents and/or oversees CRO responsibility for essential documents.
• Provides Regulatory with Site Essential Regulatory Documents for submission to the FDA and other regulatory agencies .
• Develops and ensure compliance with clinical monitoring plan; conducts or oversees co-monitor as needed for staff training and quality assurance (QA) purposes.
• 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 trial.
• Maintains a complete and updated regulatory file for each assigned site.
• Manages safety reporting to sites and regulatory agencies.
• Manage or provide oversight of CROs, independent field monitors and other clinical vendors.
• Ensures monitoring trip reports are reviewed and track resolution of all action items and protocol deviations.
• Manage, 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.
• Audit clinical data reports for accuracy, safety, and/or efficacy trends; as necessary prepare related presentations.
• Contribute to SOP review process.
• Demonstrate excellent knowledge of ICH guidelines, FDA regulations, and company SOPs related to clinical studies and coach junior staff on the same.
• Ensure Trial Master File is maintained throughout the study.
• Manage direct reports and monitor assigned activities.
• Provide frequent study updates to senior management upon request.
• Practices professionalism and integrity in all actions and in 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. Demonstrated ability to foster and imbue concepts of teamwork, cooperation, self- mastery, and flexibility to get the work done.  Maintains composure under difficult circumstances.

Preferred Education and Experience:

• Minimum BS / BA (science or health care field) or nursing degree
• Minimum of 8 years of experience in a biotech or pharmaceutical company, leading cross-functional clinical activitie
• Management experience in including outsourcing to Contract Research Organization (CRO)

Preferred Skills, Qualifications, or Technical Proficiencies:

• Attention to detail and ability to prioritize tasks to meet critical deadlines
• Excellent verbal and written communication skills
• Able to collaborate effectively with the study team, cross-functional team members, and external partners
• Excellent knowledge of US and GCP/ICH regulations
• Strong 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
• Excellent verbal and written communication skills
• Strong organization and time management skills
• Strong Proactivity and risk management skills
• Ability to develop and deliver compelling presentations

This position may supervise the following positions:

• Clinical Trial Managers
• Clinical Research Associates
• Clinical Operations Consultants