I.T. Solutions, Inc.
Senior Clinical Trial Manager
I.T. Solutions, Inc., Sunnyvale, California, United States, 94087
Our Client is a genomic medicine company focused on treating debilitating neurological diseases, by using our wholly owned, highly versatile zinc finger epigenetic regulation technology and capsid delivery engine. We are passionate about designing and developing genomic medicines to transform the lives of patients suffering from severe diseases with our deep scientific expertise and proprietary zinc finger genome engineering technology. At our client, we are dedicated to building a robust, sustainable genomic medicine pipeline that addresses life-limiting conditions by replacing today's symptom-focused treatments with tomorrow's genomic cures. Our top priority is to meet the needs of patients with commitment and compassion. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Our client is a company where individuals can flourish, grow and develop their expertise.
We are seeking top talent to join our mission. Let's build a better future together.
JOB SUMMARY:
The Temporary Senior Clinical Trial Manager is accountable for the day-to-day operations of assigned clinical trials, including start-up, conduct and close-out activities. This position will perform required job duties with guidance to ensure trial timelines, costs and quality metrics are met and the trial is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements.
ESSENTIAL FUNCTIONS:Essential functions include, but are not limited to the following:
Serve as the primary contact for managing protocol execution, including oversight of the CRO, service providers, and consultants that are involved in a clinical trialLead cross-functional study team in support of study deliverablesEstablish study milestones and ensure accurate tracking and reporting of study metrics and timelinesEnsure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPsssist in preparation and review of clinical documentation such as protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, case report form, statistical analysis plan, clinical study reports, and other study level documentsEnsure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviewsParticipate and respond to Quality Assurance and regulatory authority inspection auditsResponsible for and participates in service provider selection process as a part of outsourcing activities.Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providersIn conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documentsManage clinical trial budgets, providing ongoing financial reporting and projectionsPerform and manage data review process on an ongoing basisNegotiate and finalize site contracts and budgetsPerform site visits including oversight, site qualification, initiation, monitoring and close-out visits, as neededPlan and coordinate Investigator MeetingsEDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
Bachelor's, or equivalent, degree in a scientific discipline6+ years of clinical research experience, with at least 2 years' experience in planning and managing clinical trialsUnderstanding of pharmaceutical regulatory requirements, both US and abroadDemonstrated knowledge of ICH and GCPbility to independently manage the initiation, monitoring and closing of clinical studies in accordance with our client's policies and proceduresUnderstanding of clinical trial processes and experience in driving execution, from study start-up through study closure, (e.g., data management, safety, biostatistics, medical writing)Self-motivated, assertive and able to function independently or as part of a teamEffective in selection of investigative sites, CROs, and vendors and management of external resourcesHighly effective communication and organizational skillsble to travel 25%-30%
The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.
I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
We are seeking top talent to join our mission. Let's build a better future together.
JOB SUMMARY:
The Temporary Senior Clinical Trial Manager is accountable for the day-to-day operations of assigned clinical trials, including start-up, conduct and close-out activities. This position will perform required job duties with guidance to ensure trial timelines, costs and quality metrics are met and the trial is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements.
ESSENTIAL FUNCTIONS:Essential functions include, but are not limited to the following:
Serve as the primary contact for managing protocol execution, including oversight of the CRO, service providers, and consultants that are involved in a clinical trialLead cross-functional study team in support of study deliverablesEstablish study milestones and ensure accurate tracking and reporting of study metrics and timelinesEnsure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPsssist in preparation and review of clinical documentation such as protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, case report form, statistical analysis plan, clinical study reports, and other study level documentsEnsure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviewsParticipate and respond to Quality Assurance and regulatory authority inspection auditsResponsible for and participates in service provider selection process as a part of outsourcing activities.Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providersIn conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documentsManage clinical trial budgets, providing ongoing financial reporting and projectionsPerform and manage data review process on an ongoing basisNegotiate and finalize site contracts and budgetsPerform site visits including oversight, site qualification, initiation, monitoring and close-out visits, as neededPlan and coordinate Investigator MeetingsEDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
Bachelor's, or equivalent, degree in a scientific discipline6+ years of clinical research experience, with at least 2 years' experience in planning and managing clinical trialsUnderstanding of pharmaceutical regulatory requirements, both US and abroadDemonstrated knowledge of ICH and GCPbility to independently manage the initiation, monitoring and closing of clinical studies in accordance with our client's policies and proceduresUnderstanding of clinical trial processes and experience in driving execution, from study start-up through study closure, (e.g., data management, safety, biostatistics, medical writing)Self-motivated, assertive and able to function independently or as part of a teamEffective in selection of investigative sites, CROs, and vendors and management of external resourcesHighly effective communication and organizational skillsble to travel 25%-30%
The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.
I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.