Canada
Global Clinical Operations Specialist with 10 years of experience supporting end-to-end study management lifecycle (5yrs each in clinical operations and in project management). Managed phase II and III cardiovascular, renal, oncology, neurology and ophthalmology studies from study start up to conduct and close out stage. Specialized in Study start up; project management; clinical operations and study management.
-Clinical Trial Manager for phase I and III oncology pharmaceutical trials -Worked on neurology and ophthalmology trials -Study Start Up Specialist for assigned sites and manage successful site activations -Collaborate with global team, CRAs, vendors, system access specialists for seamless execution of site activation -Lead and prepare SIV slides and schedule site initiation visits -Review and provide feedback on site ICFs for IRB submissions -Oversee site management activities of CRAs by reviewing site management reports and data management reports -Manage site recruitment and retention activity -Launched payment vendor -Oversee CTA’s review of trial master file audit -Site closure activities
• Assisted Study managers with project-related activities, including planning, implementation, closure and evaluation of internal and external projects as part of clinical team • Maintained internal databases, tracking systems and project plans. Handled logistics, labelling and shipping materials to sites. Updated CTMS and eTMF systems • Was promoted to central regulatory monitor (in-house CRA)
Document specialist managing content/ e-training - SOPs, protocols - for 7 accounts (large pharmaceutical companies) under project management • Analyzed, prepared and distributed status, tracking and project finance reports for internal and external stakeholders • Established process improvements in metric production, including developing training material (SOPs) for team members • Tracked meetings and ensured timely implementation of customer expectations, via liason across multiple teams • Created innovative solutions to troubleshoot issues and brought in expertise through cross-collaboration when necessary • Produced quarterly metric reports – key performance indicators for presentation at Joint Operating Committee (JOC) meetings – using internal database systems, in combination with MS Excel and/or Spotfire
• QC of key project milestones to ensure deliverables are met within set timeframe • QC’ed 4 projects per day (project KPIs) with 100% accuracy rate
1. Chemical analysis of patient sputum samples and manual screening for TB positive slides- Acid Fast Bacilli Staining (Sputum Microscopy) 2. Co-ordination with RNTCP- Revised National TB Control Programme at St. John’s Hospital 3. Culture of Mycobacterium spp. from patient samples 4. Maintaining patient records, filing and coding patient information into system; Prompt reporting of results to Microbiology Dept at St. Johns hospital 5. Detection of acid-fast bacilli in sputum, Broncho-alveolar lavage(BAL), lymph nodes, urine, ovarian abscess, CSF and other specimens by DNA Strip technology 6. Handling Media preparation 7. Biowaste management