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.
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.
- Phase I: Muscle spasms (Parkinson)
- Phase IV: Ophthalmology, Respiratory (COPD), Influenza vaccine, & Psoriasis
- Phase II: Psoriasis & Diabetes
- Phase III: Gout, Hepatitis C, Liver Transplant, PE/DVT & Schizophrenia
- Phase IV: Vaccines (HPV & HIV)
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
Strategic thinkingProblem solvingAdaptabilityAttention to detailAnalytical thinkingCollaborationCreative thinkingDiligenceEfficiencyFlexibilityKindnessOptimismProactivityResult OrientedSelf-confidenceSelf-disciplineTrust
Skills and Expertise
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