Clinical Trial Manager

Job Description:

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.

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 close out, 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 strive 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 stakeholder.
• Creates 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 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 provide oversight of CROs, independent field monitors and other clinical vendors.
• Ensures monitoring trip reports are reviewed and track resolution of all action items in a timely manner, 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 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 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.
• Travel may be up to 30% occasionally
• This position may supervise the following positions: Clinical Operations Consultants and Clinical Research Associates

Preferred Education and Experience:

• Minimum BS / BA (science or health care field) or nursing degree
• Minimum of 6 or more years’ experience as a CRA or field monitor in a biotech or pharmaceutical company or CRO
• Study related management experience

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 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.