Bisma S. Email & Phone Number

Guelph, Ontario, Canada

• Plans in the development of clinical projects and where applicable, comprehensive client programs involving multiple service solutions such as regulatory, non-clinical, clinical, bioanalytical and analytical solutions.
• Leads the proactive identification and management of risks or issues identified within a client program throughout the project lifecycle and leads the team in the creation of mitigation strategies to reduce overall.
• Identifies critical project success factors for tracking, analysis and reporting

Guelph, Ontario, Canada

• Oversees the safety aspects of assigned clinical studies, including adverse events, safety reporting and laboratory testing in consultation with the PM; when appropriate, assists the PM in discussions with clients on.
• Ensures study participants at all study sites receive appropriate clinical care and that any safety concerns are identified quickly and addressed appropriately.
• Writes with Investigative New Drug (IND) / Clinical Trial Application (CTA) safety narratives in accordance with Health Canada, FDA, and ICH E2 reporting standards.
• Assigns sponsor casualty for SAE reports by assessing the relationship of events to the investigational product, evaluates expectedness of the events according to reference safety information (e.g., Investigator’s.
• Oversees the processing of Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), etc. to clients and regulatory agencies.
• Provides medical reviews of SAE information.

Guelph, Ontario, Canada

• Manages, plan and provides leadership for execution of single and multi-centric clinical studies, ensuring consistency and compliance with protocol, standard process, policies and procedures
• Develop integrated project management plans and tools to monitor study progress ensuring study executes within study timelines and budget
• Interact with relevant project stakeholders including sponsors, internal team, investigators, and vendors to analyze status of project and identify critical project success/issues for tracking and reporting. Implement.
• Oversee project budgets and monitors resource utilization throughout the program life cycle, initiating change orders and statements of work as new scope/projects arise
• Performs financial tasks including milestone billing, forecasting, project scope reviews and amendments, and pass-through cost management
• Oversees and assist in development of protocol, regulatory document, CRFs, data management and monitoring plans, vendor contract and other documents required for project implementation and evaluation

Mississauga, Ontario, Canada

Lead and Support Clinical Operations team in planning, execution and management of clinical trials; monitoring, qualitycontrol/assurance, risk management & mitigation, ensuring timelines/milestones are met with adequate resources· Liaise with key study personnel like Pharmaceutical Sponsor Monitors, Project Managers, Auditors and DataManagement· Plan.

Mississauga

• Supervise all activities concerning controlled drugs, as specified in the license.
• Ensure that weekly physical inventory of all controlled drugs is performed and maintain appropriate records.
• Assigned an organized process for drug shipment to ensure all drugs are shipped in compliance with the Health Canada regulations
• Manage, and support monthly reports of sales, generate scheduled reports for Health Canada and support drug label preparation for studies as required in collaboration with the Quality Department

Ontario, Canada

• Independently lead the overall management of clinical studies for BE/ EEC chamber and Phase 1-4 studies, involving recruitment, screening, and coordination of patient visits
• Develop and maintain study budget, study timelines, study resources and update tracking systems appropriately for ongoing studies
• Provide leadership, coordination, and management of the team through start-up, conduct, tracking, quality, and regulatory compliance management, and close-out activities
• Conduct Operational kick-off meetings and regular study update meetings to ensure open lines of communication are maintained between study managers, team members, and sponsors
• Systematized Study & Regulatory document collection, management, review, and archiving processes
• Mediate trainings with Principal Investigator ensuring study protocol, trial requirements, and quality control processes are understood and implemented by the team

Ontario, Canada

Monitor subject safety while they are in confinement in compliance with the study protocols, SOP's regulatory requirements and fulfill business needs of the company. · Coordinate Clinical Research Studies in accordance with the approved protocol and in compliance with all GCP/ICH, and institutional guidelines. · Maintain study binders, communicate with.

Pakistan

· Managing Data entry process· Managing the daily flow of information on study appointments and data collection between field sites and the study center· Assist with the training of field site staff in data entry· Perform data related tasks involved with the ongoing maintenance of participant databases (including tracking of participants and updating.

Bachelor Of Medicine, Bachelor Of Surgery - Mbbs

Certification, Medical/Clinical Assistant

Cpr, First Aid