Clinical Trials Manager

2 weeks ago

Mon Village, India Fladger Associates Full time
Foster City CAContract Duration: 636 monthsRate: Negotiable

Responsibilities:

  • Excellentemployment opportunity for a Clinical Trials Manager in the FosterCity CA area. Hybrid
  • Clinical Operations isresponsible for the worldwide execution of all Phase I IV clinicaltrials across all company therapeutic areas.
  • Clinical Operations plays a key role in ensuring allcompany clinical trials are performed in accordance with applicableSOPs company policies and regulatory guidelines to provide timelyand highquality clinical data that supports global registration andcommercialization of companys products.
  • Willwork with and collaborate with Clinical Operations BiomarkerSciences Clinical Pharmacology and other crossfunctional teammembers.
  • Manage certain components ofclinical studies and act as a member of the study team.
  • Also manage biomarker and bioanalytical vendors.
  • Assist in the review of clinical studyprotocols and other study documents contribute to processdevelopment and/or participate in special projects.
  • Serves as the key biomarker and bioanalytical operational(BBOps) contact with internal and external stakeholders forsuccessful implementation of biomarker and
    bioanalyticalstrategies in company and Collaborative (CO) programs
  • Participate in multiple Phase 14 clinical studyteams
  • Plans and coordinates all operationalactivities required with the collection delivery and analysis ofbiological specimens within a clinical trial
  • Provides sample management expertise to the StudyManagement Teams (SMTs) Biomarker SubTeams (BSTs) and ClinicalPharmacology Subteams (CPST)
  • Accountable forensuring biological samples collected are of good analyzablequality and are collected in adherence to the highest standards ofethics and informed
    consent.
  • Primary interface for operational activities between theSMT and laboratory vendors; Provides the daytoday operationalmanagement of vendors to ensure delivery
    data againstcontracted scope of work.
  • Has ability tocritically evaluate scientific proposal or protocol and budget forclinical operation feasibility
  • Establishesstrong crossfunctional relationships and exhibits strong leadershipskills with counterparts in other functional teams (e.g. BiomarkerSciences Vendor
    Outsourcing Clinical Operations and DataManagement) to ensure efficient execution of the study biomarkerstrategy.
  • Proactively identifies potentialoperational challenges and in collaboration with senior teammembers provides resolution plans to ensure biomarker strategyremains
    on track.
  • Organizes andleads Biomarker and Bioanalytical operational meetings with studyfunctional groups or vendors.
  • Maintainsinternal Biomarker and Bioanalytical Operations databases anddocument repositories.
  • Review of relevantdocuments including protocols informed consents and relevant studydocuments
  • Must be able to understand interpretand explain protocol requirements to others.
  • Assists in determining the activities to support aprojects priorities within functional area.
  • Contributes to development of RFPs and participates inselection of CROs/vendors.
  • Able to examinefunctional issues from an organizational perspective
  • Develops tools and processes that optimize projectefficiencies and effectiveness.
  • May contributeto development of abstracts presentations andmanuscripts
  • Must be able to participate inmultiple departmental or interdepartmental strategic initiativesunder limited supervision.
  • Must have a generalfunctional expertise to support Process development andimplementation.
  • Provides knowledge andexpertise on country specific regulations
  • Participates in and manages project meetings andconference calls with vendors and crossfunctional teams.
  • Develops tools and processes that optimize projectefficiencies and effectiveness.
  • Provides inputinto study protocols and case report forms authors informedconsents study plans and presentations.
  • May berequired to present at internal or external meetings (i.e.investigator meetings).
  • Leads or otherwiseassists in the preparation of interim and final study reportsincluding resolving any data discrepancies when biomarker data isneeded for primary secondary or support.
  • Proactively identifies potential operational challengesand collaborates with other Clinical Operations colleagues toprovide solutions to ensure study execution remains on track todefined protocols budgets and timelines.
  • Ensures own work complies with established practicespolicies and processes and any regulatory or otherrequirements.

Experience:

  • PharmD / PhD with 2 years relevant Clinical orrelated experience in Life Sciences.
  • MA / MSwith 3 years relevant Clinical or related experience in LifeSciences.
  • BA / BS / RN with 5 years relevantClinical or related experience in Life Sciences.
  • 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.
  • Ability tomanage any component of full cycle study management from startup tocloseout.
  • Advanced knowledge of studymanagement best practices and tools and has shown ability to applythese to improve study efficiencies and effectiveness.
  • Fully understands protocol requirements and effectivelyarticulates and interprets these.
  • Thoroughknowledge of Food & Drug Administration (FDA) EuropeanMedicines Agency (EMA) and other applicable national regulationsInternational Council for Harmonization of Technical Requirementsfor Pharmaceuticals for Human Use (ICH) guidelines and GoodClinical Practice (GCP) governing the conduct of clinicalstudies.
  • Familiar with standard medical /scientific terminology.
  • Experience managingthe work of external vendors.

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