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, to meet overall project or program objectives• 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 risk profile through implementation of preventative measures, effectiveness checks, deviation management and corrective actions• 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 safety issues or concerns that may have arisen• 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 Brochure), and determines if the SAE meets reportability criteria as per applicable regulations.• 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.• Review cumulative safety information as part of study safety management.• Proposes changes to study protocol or Informed Consent Form, if warranted by the severity or frequency of adverse events.• Provides coverage for emergency medical guidance outside of normal business hours (as needed).• Reviews and addresses all medical alerts for assigned studies.• Conduct medical review of MedDRA-coded terms for adverse events and medical histories, and WHO Drug-coded terms for concomitant medications/therapies (as required). • Assists in the set up and conduct of Data Safety Monitoring Boards (DSMB), Data Monitoring Committees (DMC) or similar, as required.• Prepares Safety Management Plans as required.• As required, advises, and assists clients on product development, study designs, endpoint analyses and the feasibility of conducting Phase I to IV clinical studies

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 corrective measures as needed.• 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 strategically for trial conduct, and manage study budgeting and finances· Ensure timely communication with sponsors, investigator(s) and managers with respect to medical/ nonmedical subjectissues as well as trial planning within budget· Develop and manage project timelines, study resources and update internal tracking systems appropriately for ongoingstudies· Coordinate client monitoring and audit visits as well as regulatory audits· Work with the Quality Assurance team in the development/revision/harmonization and implementation of StandardOperating Procedures as required· Assist the Manager of Clinical Operations in making decisions regarding hiring and conducting interviews, staffpromotion/termination and creation of staff schedules· Support Human Resources Team in procuring documentation from new hires as well as conduct yearly performanceevaluation for all staff· Work with Quality Assurance to ensure there is an appropriate audit plan for every trial· Ensure strict adherence to SOPs and work towards process improvement.

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●Regulate efficient monitoring and tracking of data, ensuring minimal deviations, to meet project goals. ●Design, implement, and coordinate of all aspects of data collection, source documentation, data entry and CRF transcription as per protocol, Standard operating procedures (SOPs) and ICH/GCP (Good Clinical Practices) guidelines

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 sponsor, updates shift reports etc. · Obtain Medical History and Informed Consent from potential trial subjects. · Review and Perform ECG, Vitals, obtain blood sample, anthropometrics, drug screen etc. · Dispense and administer study drug, maintain drug log as well. · Monitor and maintain Crash cart and perform Advanced Medical Directives in case of emergency as per Principal Investigator. · Initiate and report Adverse events and Serious Adverse events in compliance with Drug safety regulations and standards. · Maintain accuraate, complete, legible and timely data entry (eCRF). · Review (QC) documentation and maintain Study binder as per Protocol and SOP requirements.

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 participant’s status)

Bachelor Of Medicine, Bachelor Of Surgery - Mbbs

Certification, Medical/Clinical Assistant

Cpr, First Aid