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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.


Current Experience

  • Clinical Project Manager (Local Studies) Sydney, New South Wales, Australia
    Since May 2013

    • 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.



    • 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


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


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


  • 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 0

Training and Certification

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


BrightOwl Assessment:
Self Assessment:
Full Proficiency
Full Proficiency
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:

Area / Region

Sydney, New South Wales, Australia


Driving License
  • Yes