Senior Clinical Trial Manager (Sr CTM)

Location
Menlo Park, CA
Posted
May 20, 2022
Ref
4355207004
Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Full time

Corcept is engaged in the discovery and development of drugs that treat severe endocrine, metabolic, oncologic and neurological disorders by modulating the effects of the hormone cortisol. Since 2012, we have marketed Korlym® for the treatment of patients suffering from Cushing’s syndrome, a life-threatening orphan disorder caused by excess cortisol activity.

In addition to our commercial product, Korlym, we have discovered a portfolio of more than 1,000 proprietary selective cortisol modulators.  Lead compounds are in Phase 2 and Phase 3 trials for the treatment of patients with Cushing’s syndrome, advanced ovarian cancer, castration-resistant prostate cancer, weight gain caused by antipsychotic medications and non-alcoholic steatohepatitis (“NASH”).  We are about to start a Phase 2 trial in patients with amyotrophic lateral sclerosis (“ALS”).

In 2021, we generated revenue of $366 million and net income of $112 million.

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 CROs (when applicable) to execute the requirements of the protocol and ensure overall study deliverables, milestones, and objectives 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, 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
  • 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.
  • Procures and manages 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 CRAs but will be ultimately responsible for the quality of the documents
  • Develops study timelines and budgets per the corporate and departmental goals and continuously strives to ensure timelines are deliverables are met within budget
  • Tracks and manages 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 ensures 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
  • Liaises with chemistry, manufacturing, and controls (CMC) team to forecast and monitor overall drug supply and expiration to ensure adequate availability throughout the 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
  • 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
  • Audits clinical data reports for accuracy, safety, and/or efficacy trends; as necessary prepare related presentations
  • Contributes to the SOP review process
  • Demonstrates excellent knowledge of ICH guidelines, FDA regulations, and company SOPs related to clinical studies and coaches junior staff
  • Ensures the Trial Master File is maintained throughout the study
  • Manages direct reports and monitor assigned activities
  • Provides frequent study updates to senior management
  • 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. 

Preferred Education and Experience: 

  • Relevant BS / BA degree or nursing degree
  • 8+ years' experience in a biotech or pharmaceutical company, leading cross-functional clinical activities
  • Management experience 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
  • 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
  • Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools 

This position may supervise the following roles: 

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

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

If you are based in California, we encourage you to read this important information for California residents linked here.

 

Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

 Please visit our website at: https://www.corcept.com/

Corcept is an Equal Opportunity Employer