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Clinical Trials Manager Consultant

Company: Clinical Dynamix, Inc.
Location: Richmond
Posted on: March 27, 2020

Job Description:

TITLE: Clinical Trial Manager6 month contract (renewable up to 4 years). Can also convert to perm/ FTE role. This role sits in their Richmond, CA office but can also work 2 days/week form their Brisbane, CA officeJOB SUMMARY:The 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 SOPsAssist 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 outsourcingResponsible 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 Meetings EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:Bachelors, 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 GCPAbility to independently manage the initiation, monitoring and closing of clinical studies in accordance with Client policies and procedures Understanding 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 team Experience in selection of investigative sites, CROs, and vendors and management of external resourcesHighly effective communication and organizational skillsAble to travel 25%-30%

Keywords: Clinical Dynamix, Inc., Richmond , Clinical Trials Manager Consultant, Healthcare , Richmond, California

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