TM Ops Specialist

San Francisco, CA | Full Time | Clinical Operations

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Job Description

Job Summary

TM Operations works across all programs partnering primarily with colleagues in Clinical Development, Clinical Operations, Molecular Diagnostics, Translational Medicine Research, and Global Medical Affairs to ensure robust clinical sample management that is in compliance with protocols, regulatory guidance and project timelines.

TM Ops Specialists possess the desire and ability to learn about the disease and clinical indication of the compound in clinical development, as well as the molecular diagnostic tools used in companion diagnostic development for targeted therapies. This basic understanding will be used by the Specialist to design/develop first-in-class laboratory manuals, study tools and presentations to educate and support clinical site staff in collecting, processing and shipping quality bio-specimens. Managing key service providers, Specialists are responsible for timely delivery of sample collection kits, overseeing the global transport of clinical trial samples, preparing sample electronic manifests and managing the inventory of samples at Clovis' off-site bio-repository.

 

Job Responsibilities

  • Tracks laboratory samples and follows up with sites/study team/CRO to resolve queries
  • Develops ability to organize and manage large datasets and present regular summaries to teams
  • Ensures 3rd party vendor deliverables are of high quality and in line with study timelines
  • Designs/develops protocol-specific laboratory manuals, study tools and presentations to be utilized for training study site staff
  • Interacts with investigators, study coordinators and study teams/CROs through written and verbal communication to maintain effective management of specimen management issues ensuring accuracy and completeness
  • Assists with manual in-house review of CRF data in clinical database for completeness and accuracy
  • Assists with review of clinical/regulatory documents pertaining to research use of bio-specimens including informed consent forms, site-and country-specific applications related to bio-specimens, to ensure completeness, accuracy and timeliness
  • Ensures study records are auditable both at investigational sites, in-house and at Clovis' off-site bio-repository and analytical labs, if applicable
  • Develops independence in performing routine work and assists in designing metrics to evaluate efficiency of overall sample management process
  • Communicates status of trial to manager and team
  • Professionally represents TM Operations within Clovis, with service providers and with investigative study teams

Skills & Requirements

Qualifications

  • Biological experience and/or understanding of various DNA, RNA and protein based biomarker assays and application to our drug candidates and companion diagnostics
  • Excellent verbal and written communication skills
  • Successful candidates must possess outstanding organizational skills and be able to focus on details with commanding follow through
  • Working knowledge of GCP and FDA regulations
  • Proficiency in MS Word, Excel and PowerPoint

    Education and Experience

  • BA/BS in Molecular/Cellular Biology, Pharmacology or equivalent, with 3+ years relevant industry experience
  • Experience in translational medicine research and/or clinical research in an academic or bio-pharmaceutical setting
  • Proficient with clinical and biological data management
  • Experience managing central lab and third party vendors and ensuring data is generated and transferred in compliance with recommended procedures
  • Background knowledge of cellular and molecular biology, common biological assays (eg: microarrays, sequencing etc.) and drug development processes
  • Self-motivated and capable of working effectively in a fast-paced team environment
  • Excellent presentation and oral/written communication skills

    Working Conditions

    Typically no to limited travel