Sr Clinical Trial Management Associate

3 months ago


Mon Village, India Fladger Associates Full time
  • Foster CityCA
  • Contract Duration:636 months
  • Rate:Negotiable

Responsibilities:

  • Excellent employment opportunity for a Sr.Clinical Trial Management Associate (Senior CTMA) in the FosterCity CA area.
  • FUNCTION: Clinical OperationsBiomarker and Bioanalytical Operations
  • Clinical Operations is responsible for the worldwideexecution of all Phase I IV clinical trials across all companytherapeutic areas.
  • Clinical Operations playsa key role in ensuring all company clinical trials are performed inaccordance with applicable SOPs company policies and regulatoryguidelines to provide timely and highquality clinical data thatsupports global registration and commercialization of companysproducts.
  • Support other Clinical Operationsteam members in the startup maintenance and closeout of clinicalstudies.
  • May manage certain components ofclinical studies and act as a member of the study team.
  • May also manage vendors and/or manageinvestigatorsponsored research.
  • May assist inthe review of clinical study protocols and other study documentscontribute to SOP development and/or participate in specialprojects.
  • Leads or manage components of PhaseI II or III studies
  • Assists Biomarker SciencesClinical Virology and/or Clinical Pharmacology in vendor selectionand coordinates all interactions and deliverables fromvendors.
  • May assist as operational contact forcompany studies
  • Plans and coordinates alloperational activities required with the collection delivery andanalysis of biological samples within a clinical trial
  • Manages study timelines including documentation andcommunications
  • Serves as the point of contactwith internal and external stakeholders for successfulimplementation of all biological sample analysis strategy incompany and Collaborative (CO) programs
  • Participates in and manages project meetings andconference calls with CROs other vendors and crossfunctionalteams.
  • Participates in the functional reviewof study protocol and other study related documents such asclinical sample management plan study communication plan orpresentations for Investigator and/or Study KickOffmeeting.
  • Participates in the review andapproval of main study and optional informed consents and mayreview additional study specific informed consents
  • Contributes to SOP development and/or participates inspecial projects
  • Develops tools and processesthat optimize project efficiencies and effectiveness.
  • Proactively identifies potential operational challengesand collaborates with key stakeholders to provide solutions toensure study execution remains on track to projected budgets andtimelines.
  • Ensures own work complies withestablished practices policies and processes and any regulatory orother requirements.

Experience:

  • MA/ MS / PharmD/ PhD with 2 years relevant clinical or related experience in LifeSciences.
  • BA / BS / RN with 4 years relevantclinical or related experience in life sciences.
  • Experience in managing the work of externalvendors.
  • Meets all requirements for ClinicalTrial Management Associate (CTMA)
  • Demonstrated ability to be a fast learner.
  • Demonstrated ability to be flexible and adaptable tochange to move between projects easily and providesupport/expertise where needed.
  • Knowledge offull cycle clinical study management from startup to closeout andhas shown ability to effectively apply this knowledge to achievetargeted study outcomes.
  • Significant industryknowledge.
  • Complete knowledge of Food &Drug Administration (FDA) and European Medicines Agency (EMA) andother applicable national regulations International Council forHarmonisation of Technical Requirements for Pharmaceuticals forHuman Use (ICH) guidelines Good Clinical Practice (GCP) and keyClinical Operations principles concepts practices standardsprocesses and tools.
  • Familiar with standardmedical / scientific terminology.
  • Ability tocommunicate in a clear and concise manner.
  • Ability to support a teamoriented highly matrixedenvironment.
  • When needed ability totravel.
  • Top 3 Required Skill Sets: samplemanagement experience strong Microsoft skills excellentcommunication skills
  • Top 3 Nice to Have SkillSets: clinical operations/bioanalytical operations experiencelaboratory (bench) experience


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