Corcept Therapeutics
Clinical Trial Manager
Corcept Therapeutics, Redwood City, California, United States, 94061
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.
Responsibilities:
Responsible for the implementation and quality execution of assigned clinical protocols according to Corcept SOPs, ICH/GCP, and corporate and department program goalsMay 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 budgetOversees aspects of study management and vendors to ensure high quality of dataProviding Clinical Research Associates with project-specific training, guidance, and oversight, assigning deliverables and having regular meetings with themDevelops clinical trial protocol synopsis, protocols, amendments as directed by the Clinical Development team and while working with Medical WritingDevelops critical study documents such as informed consent form templates, site management, and monitoring toolsEvaluates study designs from an operations perspective, and considers site implementation tactics to suggest feasible solutions and contribute to overall program design and executionDevelops study timelines and budgets per the corporate and departmental goals and continuously strives to ensure timelines and deliverables are met within budgetResponsible for tracking and managing study execution to resources and goalsFacilitating 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 executionEscalates concerns regarding timelines, milestones, resourcing, and any potential study execution issue to appropriate internal stakeholdersCreates a process for developing distribution, reviews, and tracking essential trial documents and/or oversees CRO or CRA responsibility for essential documentsCollaborates 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 AmendmentsDevelops and ensures compliance with clinical monitoring plan; conducts or oversees co-monitor as needed for staff training and quality assurance (QA) purposesMay conduct and/or attend PSVs, SIVs, IMVs, and COVsPartners in the development of the case report form (CRF) design process including content, form layout, and edit check reviewLiaison with chemistry, manufacturing, and controls (CMC) team to forecast and monitor overall drug supply and expiration to ensure adequate availability throughout the trialEnsures CRA(s) maintain a complete and updated regulatory file for each assigned siteManages oversight of Investigational Product (IP) accountability and ensures adequate site supplyManages safety reporting to sites and regulatory agenciesProcures and manages contracts with CROs, study vendors, and investigative sitesManages and/or provides oversight of CROs, independent field monitors, and other clinical vendorsEnsures monitoring trip reports are reviewed and track resolution of all action items on time, per the Monitoring Plan or Corcept SOPsCo-monitors at investigative sites to evaluate study site and field monitor performanceManages, 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 qualityServes as in-house contact for protocol-related process questions and tracks questions/processes for best practices and consistencyMay help audits clinical data reports for accuracy, safety, and/or efficacy trends; as necessary prepare related presentationsExercises 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 sitesContribute to the SOP review process and other Clinical Operations Initiatives, as necessaryDemonstrates excellent knowledge of ICH guidelines, FDA regulations, and company SOPs related to clinical studies and coach junior staff on the sameEnsures Trial Master File is maintained throughout the studyPractices 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 circumstancesTravel may be up to 30% occasionallyThis position may supervise the following positions: Clinical Operations Consultants and Clinical Research AssociatesThis headquarters-based role requires on-site attendance three days a weekPreferred Education and Experience:
Relevant BS / BA degree or nursing degree6+ years' experience as a CRA or field monitor in a biotech, pharmaceutical, or CRO companyStudy-related management experiencePreferred Skills, Qualifications, or Technical Proficiencies:
Attention to detail and ability to prioritize tasks to meet critical deadlinesExcellent verbal and written communicationAble to collaborate effectively with the study team, cross-functional team members, and external partnersKnowledge of US and GCP/ICH regulationsUnderstanding of the clinical trials process, the application of SOPs, and medical terminologyStrong interpersonal, problem-solving, and organizational skillsSelf-motivated and able to motivate othersSound judgment and discretionAttention to detail and ability to prioritize tasks to meet critical deadlinesAbility to read and understand scientific literatureStrong organization and time management skillsAbility to develop and deliver compelling and concise presentationsAble to work effectively on project teams and independentlyStrong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools
The pay range that the Company reasonably expects to pay for this headquarters-based position is $152,100 - $178,900; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
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.
For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
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
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.
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.
Responsibilities:
Responsible for the implementation and quality execution of assigned clinical protocols according to Corcept SOPs, ICH/GCP, and corporate and department program goalsMay 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 budgetOversees aspects of study management and vendors to ensure high quality of dataProviding Clinical Research Associates with project-specific training, guidance, and oversight, assigning deliverables and having regular meetings with themDevelops clinical trial protocol synopsis, protocols, amendments as directed by the Clinical Development team and while working with Medical WritingDevelops critical study documents such as informed consent form templates, site management, and monitoring toolsEvaluates study designs from an operations perspective, and considers site implementation tactics to suggest feasible solutions and contribute to overall program design and executionDevelops study timelines and budgets per the corporate and departmental goals and continuously strives to ensure timelines and deliverables are met within budgetResponsible for tracking and managing study execution to resources and goalsFacilitating 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 executionEscalates concerns regarding timelines, milestones, resourcing, and any potential study execution issue to appropriate internal stakeholdersCreates a process for developing distribution, reviews, and tracking essential trial documents and/or oversees CRO or CRA responsibility for essential documentsCollaborates 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 AmendmentsDevelops and ensures compliance with clinical monitoring plan; conducts or oversees co-monitor as needed for staff training and quality assurance (QA) purposesMay conduct and/or attend PSVs, SIVs, IMVs, and COVsPartners in the development of the case report form (CRF) design process including content, form layout, and edit check reviewLiaison with chemistry, manufacturing, and controls (CMC) team to forecast and monitor overall drug supply and expiration to ensure adequate availability throughout the trialEnsures CRA(s) maintain a complete and updated regulatory file for each assigned siteManages oversight of Investigational Product (IP) accountability and ensures adequate site supplyManages safety reporting to sites and regulatory agenciesProcures and manages contracts with CROs, study vendors, and investigative sitesManages and/or provides oversight of CROs, independent field monitors, and other clinical vendorsEnsures monitoring trip reports are reviewed and track resolution of all action items on time, per the Monitoring Plan or Corcept SOPsCo-monitors at investigative sites to evaluate study site and field monitor performanceManages, 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 qualityServes as in-house contact for protocol-related process questions and tracks questions/processes for best practices and consistencyMay help audits clinical data reports for accuracy, safety, and/or efficacy trends; as necessary prepare related presentationsExercises 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 sitesContribute to the SOP review process and other Clinical Operations Initiatives, as necessaryDemonstrates excellent knowledge of ICH guidelines, FDA regulations, and company SOPs related to clinical studies and coach junior staff on the sameEnsures Trial Master File is maintained throughout the studyPractices 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 circumstancesTravel may be up to 30% occasionallyThis position may supervise the following positions: Clinical Operations Consultants and Clinical Research AssociatesThis headquarters-based role requires on-site attendance three days a weekPreferred Education and Experience:
Relevant BS / BA degree or nursing degree6+ years' experience as a CRA or field monitor in a biotech, pharmaceutical, or CRO companyStudy-related management experiencePreferred Skills, Qualifications, or Technical Proficiencies:
Attention to detail and ability to prioritize tasks to meet critical deadlinesExcellent verbal and written communicationAble to collaborate effectively with the study team, cross-functional team members, and external partnersKnowledge of US and GCP/ICH regulationsUnderstanding of the clinical trials process, the application of SOPs, and medical terminologyStrong interpersonal, problem-solving, and organizational skillsSelf-motivated and able to motivate othersSound judgment and discretionAttention to detail and ability to prioritize tasks to meet critical deadlinesAbility to read and understand scientific literatureStrong organization and time management skillsAbility to develop and deliver compelling and concise presentationsAble to work effectively on project teams and independentlyStrong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools
The pay range that the Company reasonably expects to pay for this headquarters-based position is $152,100 - $178,900; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
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.
For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
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
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.