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Clinical Trials Manager

4 months ago

Mon Village, India TekWissen LLC Full time
Overview: TekWissen Group isa workforce management provider throughout the USA and many othercountries in the world. The below job opportunity is with one ofour Biotech clients who researches develop and commercializesdrugs. The company focuses primarily on antiviral drugs used in thetreatment of HIV hepatitis B hepatitis C and influenza includingHarvoni and Sovaldi.
Position: Clinical Trials Manager Location: Foster City CA 94404 Duration: 6 Months Job Type: Contract Work Type: Hybrid Job Description
  • ClinicalOperations is responsible for the worldwide execution of all PhaseI IV clinical trials across all clients therapeutic areas.
  • Clinical Operationsplays a key role in ensuring all
  • Client clinical trials are performed inaccordance with applicable SOPs company policies and regulatoryguidelines to provide timely and highquality clinical data thatsupports
    global registration and commercialization ofclients products.
  • You will work with and collaborate with ClinicalOperations Biomarker Sciences Clinical Pharmacology and othercrossfunctional team members.
  • You will manage certain components of clinical studiesand act as a member of the study team.
  • You will also manage biomarker andbioanalytical vendors.
  • You will assist in the review of clinical studyprotocols and other study documents contribute to processdevelopment and/or participate in special projects.
  • You may also participate instrategic initiatives.
EXAMPLERESPONSIBILITIES:
  • Serves as the key biomarker andbioanalytical operational (BBOps) contact with internal andexternal stakeholders for successful implementation of biomarkerand
    bioanalytical strategies in clients andCollaborative (CO) programs
  • Participate in multiple Phase 14 clinical study teams
  • Plans andcoordinates all operational activities required with the collectiondelivery and analysis of biological specimens within a clinicaltrial
  • Providessample management expertise to the Study Management Teams (SMTs)Biomarker SubTeams (BSTs) and Clinical Pharmacology Subteams (CPST)
  • Accountable forensuring biological samples collected are of good analysablequality and are collected in adherence to the highest standards ofethics and informed
    consent.
  • Primary interface for operational activitiesbetween the SMT and laboratory vendors;
  • Provides the daytoday operational managementof vendors to ensure delivery
    data against contractedscope of work
  • Hasability to critically evaluate scientific proposal or protocol andbudget for clinical operation feasibility
  • Establishes strong crossfunctionalrelationships and exhibits strong leadership skills withcounterparts in other functional teams (e.g. Biomarker SciencesVendor Outsourcing Clinical Operations and Data Management) toensure efficient execution of the study biomarker strategy.
  • Proactivelyidentifies potential operational challenges and in collaborationwith senior team members provides resolution plans to ensurebiomarker strategy remains
    on track
  • Organizes and leads Biomarker andBioanalytical operational meetings with study functional groups orvendors
  • Maintainsinternal Biomarker and Bioanalytical Operations databases anddocument repositories
  • Review of relevant documents including protocolsinformed consents and relevant study documents
  • Must be able to understandinterpret and explain protocol requirements to others
  • Assists in determining theactivities to support a projects priorities within functional area
  • Contributes todevelopment of RFPs and participates in selection of CROs/vendors
  • Able to examinefunctional issues from an organizational perspective
  • May contribute or participate inspecial projects.
  • Develops tools and processes that optimize projectefficiencies and effectiveness.
  • May contribute to development of abstracts presentationsand manuscripts
  • Mustbe able to participate in multiple departmental orinterdepartmental strategic initiatives under limited supervision
  • Must have a generalfunctional expertise to support Process development andimplementation
  • Provides knowledge and expertise on country specificregulations
  • Participates in and manages project meetings andconference calls with vendors and crossfunctional teams.
  • Develops tools andprocesses that optimize project efficiencies and effectiveness.
  • Provides input intostudy protocols and case report forms authors informed consentsstudy plans and presentations.
  • May be required to present at internal or externalmeetings (i.e. investigator meetings).
  • Leads or otherwise assists in the preparationof interim and final study reports including resolving any datadiscrepancies when biomarker data is needed for primary secondaryor 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 establishedpractices policies and processes and any regulatory or otherrequirements.
REQUIREMENTS:
  • We are all different yet we all use ourunique contributions to serve patients.
  • Please see the following for thequalifications and skills we seek for this role.
Minimum Education & Experience
  • PharmD / PhD with 2 years relevant clinicalor related experience in life sciences.
  • MA / MS with 3 years relevant clinical orrelated experience in life sciences.
  • BA / BS / RN with 5 years relevant clinicalor related experience in life sciences.
Knowledge& Other Requirements
  • Demonstrated abilityto be a fast learner.
  • Demonstrated ability to be flexible and adaptable tochange to move between projects easily and providesupport/expertise where needed.
  • Ability to manage any component of full cycle studymanagement from startup to closeout.
  • Advanced knowledge of study management bestpractices and tools and has shown ability to apply these to improvestudy efficiencies and effectiveness.
  • Fully understands protocol requirements andeffectively articulates and interprets these. Thorough knowledge ofFood & Drug Administration (FDA) European Medicines Agency(EMA) and other applicable national regulations InternationalCouncil for Harmonization of Technical Requirements forPharmaceuticals for Human Use (ICH) guidelines and Good ClinicalPractice (GCP) governing the conduct of clinical studies.
  • Familiar withstandard medical / scientific terminology.
  • Experience managing the work of externalvendors.
  • Ability tocommunicate in a clear and concise manner.
  • Ability to support a teamoriented highlymatrixed environment.
  • Ability to execute multiple tasks as assigned.
TekWissen Group is an equalopportunity employer supporting workforce diversity.