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Summary

clinical Project Manager with 10+ years of experience in Clinical trials (Phase I-iv) both in global CRO & Pharmaceutical companies. proven ability to manage Clinical trials "from concept to final publication" to the highest standard within deadlines.

Experiences

Current Experience

  • Clinical Project Manager (Local Studies)

    Sydney, New South Wales, Australia
    Since May 2013
    • co-responsible for: study concept, science)" rel="nofollow">Protocol writing (interventional and non-interventional trials), Statistical Analysis and Publications.
    • budget: responsible for all aspects of study budget (e.g.: spend forecast; contracts; identify cost savings/avoidance).
    • people: manage and enable cras, ctas, start up specialist and contractors to perform their roles successfully.
    • vendor management: conduct vendor selection process; contract Negotiation and execution; process improvement; budget and deliverables management.
    • recruitment: develop and implement recruitment plan; execute contingency plans as needed (e.g.: organise Patient Recruitment campaign)
    • database: responsible for designing ecrfs (including queries and identification of science)" rel="nofollow">Protocol deviations) with collaboration of medical and Data Management teams.
    • documents: author of monitoring plan, sae reconciliation plan, data transfer plan and other study documents to ensure Compliance with local sops.
    • trial management: accountable for achieving study milestones; Risk Management and contingency plans; Training; identify and resolve issues.
    • investigational drug: organise Logistics of study drug such as import license, ivrs setup, storage in the warehouse, distribution to sites, destruction and issues resolution.
    • driving feasibility & start up activities: management of site selection process, Health authority & hrec submissions and site initiations activities.

     

          achievements:

    • setup Phase IV trials under aggressive timelines (6 months from study concept to fpfv).
    • developed budget tool, Project Management & recruitment tools for the department (added to SOP).
    • identified significant costs savings for majority of global and local studies based on certain incompatibilities noticed between science)" rel="nofollow">Protocol designs and Finance systems.

         

    therapeutic experience

       

             local studies

          

             global studies

    • Co-responsible for: study concept, protocol writing (interventional and non-interventional trials), statistical analysis and publications.
    • Budget: responsible for all aspects of study budget (e.g.: spend forecast; contracts; identify cost savings/avoidance).
    • People: manage and enable CRAs, CTAs, Start up specialist and contractors to perform their roles successfully.
    • Vendor Management: conduct vendor selection process; contract negotiation and execution; process improvement; budget and deliverables management.
    • Recruitment: develop and implement recruitment plan; execute contingency plans as needed (e.g.: organise patient recruitment campaign)
    • Database: responsible for designing eCRFs (including queries and identification of protocol deviations) with collaboration of medical and data management teams.
    • Documents: author of Monitoring Plan, SAE reconciliation Plan, Data Transfer Plan and other study documents to ensure compliance with local SOPs.
    • Trial management: accountable for achieving study milestones; risk management and contingency plans; training; identify and resolve issues.
    • Investigational drug: organise logistics of study drug such as import license, IVRS setup, storage in the warehouse, distribution to sites, destruction and issues resolution.
    • Driving feasibility & start up activities: management of site selection process, Health Authority & HREC submissions and site initiations activities.

     

          Achievements:

    • Setup Phase IV trials under aggressive timelines (6 months from study concept to FPFV).
    • Developed Budget tool, Project Management & Recruitment tools for the department (added to SOP).
    • Identified significant costs savings for majority of global and local studies based on certain incompatibilities noticed between protocol designs and finance systems.

         

    Therapeutic Experience

       

             Local Studies

    • Phase I: Muscle spasms (Parkinson)
    • Phase IV: Ophthalmology, Respiratory (COPD), Influenza vaccine,  & Psoriasis

          

             Global Studies

    • Phase II: Psoriasis & Diabetes
    • Phase III: Gout, Hepatitis C, Liver Transplant, PE/DVT & Schizophrenia
    • Phase IV: Vaccines (HPV & HIV)

Past Experience

  • PM/Lead CRA Sydney, New South Wales, Australia

    January 2011 --- April 2013

     • ensuring ethical trial conduct, ich gcp Compliance, Patient Safety, data quality and timely Patient Recruitment to committed study targets

    • managing the study from start up to close out activities in australia

    • establishing local recruitment plan/trial activity milestones

    • provide project team members with trial logistic, technical and administrative support

    • regular review of study progress against project plan and recruitment plan

    • reviewing monitoring reports and regular project team meetings with cras

    • producing local updates/newsletters and arranging distribution to sites

    • tracking global study milestones to ensure successful completion of the study

    • responsible for final tmf sign off and sending tmfs for archiving budget specialist

    • budget Reviewer for all trials in icro department australia

    • updating study budget tool to facilitate project managers tracking costs

    • tracking global key performance indicators for all studies and presenting results on monthly basis to icro head

    • setting up study budget for project managers

    • assisting Finance department with the final invoice at the end of the studies

  • Clinical Research Associate (CRA)

    January 2008 --- January 2011
    • giving support to cras, sites and the study team in general • create monitoring tools and provide support to other cras • provide various study specific Training to site staff • liaising with sites and sponsors to arrange Clinical Trial agreements • provide Training to cras, inclusive presenting during the project team meetings • Budgets Negotiation between investigators, institutions and sponsors • presenting topics on study meeting overseas

  • Clinical Research Associate (CRA)

    January 2006 --- June 2007
    • prepare Ethics and regulatory submissions in accordance with local requirements • preparing local Investigator meeting • provide support to the Pharmacovigilance division • performed Data entry from sae report forms into safety Databases

Personality

Self Assessment :
Strategic thinkingProblem solvingAdaptabilityAttention to detailAnalytical thinkingCollaborationCreative thinkingDiligenceEfficiencyFlexibilityKindnessOptimismProactivityResult OrientedSelf-confidenceSelf-disciplineTrust

Knowledge

LinkedIn Assessment :
CTMSCROGCPClinical monitoringClinical trialsICH-GCPPharmacovigilanceClinical researchCommunication SkillsProtocolProject ManagementStrategic PlanningVendor ManagementPharmaceutical IndustryClinical Development

Skills and Expertise

Self Assessment :
Create SOPs Design case record forms Develop clinical trial protocols Interact with physicians Monitor a clinical study Write protocolscontrol different protocol versions and other essential documentsCoordinate logisticsCoordinate projectsCoordinate ethics committeeCreates a collaborative team environmentCreate study documentsDesign clinical trialEnsure consistency between the protocol and CRFEnsure data integrityEnsure good clinical practice (GCP)Establish contracts

Education

  • Bachelor's degree in Pharmacy in Bachelor of Pharmacy from Faculdades Metropolitanas Unidas in 2007
  • Master of Business Administration (MBA) in from Australian Institute of Business in 0000

Training and Certification

  • GCP in 2008 Training
  • GCP in 2006 Training
  • GCP in 2011 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Portuguese
Full Proficiency
Spanish
Elementary Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    associate Clinical Project Manager Global Clinical Project Manager (GCPM, GTM) Senior Clinical Project Manager (CPM) Clinical Project Manager (CPM)
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position
    BrightOwl freelancer
    BrightOwl employee
  • International:
    Yes

Area / Region

Sydney, New South Wales, Australia

Others

Driving License
  • Yes

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