Saima Naqvi

• Streamlined staff workloads in collaboration with the
  Associate Director, resulting in heightened
  productivity and adherence to benchmarks.
  • Boosted staff performance through proactive
  supervision and strategic management techniques.
  • Upheld stringent quality and performance standards
  within clinical operations.
• Supervise performance and development of staff by providing coaching and feedback to staff regarding performance
• Review daily time logging by staff for payroll and project assignment; compare time logging to Staff Schedule, and resolve discrepancies.
• Participate in hiring new employees for the department in conjunction with Human Resources staff and the department management
• Work closely with the staff scheduler to complete weekly staffing schedules for the department.
• Collaborated with other departments (Regulatory, QC, QA, labs, Pharmacy etc to coordinate workflow processes between teams.
• Addressed and resolved interpersonal conflicts within the team, maintaining a harmonious work environment.
• Preparation for regulatory submissions.
• Experience in IRB submissions.
• Experience for the preparations for Regulatory Authorities (FDA/Health Canada) Audits with the collaboration of other departments.

• Expertly directed a multifaceted portfolio of clinical
  trials, including BA/BE, Phase 1-4, and patch
  studies, guaranteeing flawless execution and
  comprehensive management.
  • Skillfully led simultaneous projects, demonstrating
  exceptional multitasking and project coordination
  capabilities.
  • Oversaw the entire project lifecycle, from Study
  start up to Close Out, ensuring all tasks were
  aligned and executed efficiently and in a timely
  manner.
  • Training and coaching of the new leads and Co
  leads for upcoming studies
  • Support Clinical Research Coordinators in the
  overall conduct of trials; problem solving, quality
  control/assurance, ensuring timelines/milestones
  are met
  • Ensure all study documents and logistical planning
  are created in a timely manner and implemented as
  approved
  • Assist staff in the conduct of day-to-day visits.
  Perform clinical and study procedures as per study
  protocol such as dosing, allergy testing etc. as
  needed.
  • Work closely with the Recruitment department for
  sufficient recruitment for the studies.
  • Ensure timely communication with Study
  Investigator(s) and Managers with respect to
  medical/non-medical subject issues
  • Prepare for QA audits, Monitoring visits .
  • Conducted meticulous reviews of study Protocols,
  Informed Consent Forms (ICF), electronic Case
  Report Forms (eCRF), and other critical study
  documents, upholding the highest standards of
  research integrity and compliance.

• Spearheaded and managed multiple concurrent
  clinical studies, ensuring seamless execution of
  inclinic procedures
• Lead/Assist Clinical Trial Operations, Assist Monitor single/multi-center trials.
• Drug Administration, Patch Application and Removal etc
• Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
• Support staff in clinic procedures, Create/review source Documents
• Conducted meticulous data entry and thorough data
  review
  • Reporting of Adverse Events

• Assist Monitor single/multi-center trials
• Subjects Check-in and Check-out, conduct of Pulse Oximetry, ECG’s, Vital Signs, Fluid Loads, and Oral Inspections, Diary Cards distribution in EEC chambers, Urine Drug test, Labeling, Assembly & meal distribution, admin work etc. assist EMT-B staff , QC and verification

Provided comprehensive administrative support,
ensuring seamless operational flow.
• Diligently maintained log book records for accurate
tracking and reporting.
• Monitored and documented operator attendance to
uphold workforce efficiency.
• Regularly updated Standard Operating Procedures
(SOPs) on-site to optimize production processes.

• Assessed patient eligibility for Non-Small Cell Lung
Cancer clinical trials, ensuring strict adherence to
study criteria.
• Facilitated the Informed Consent process, providing
comprehensive information and support to
participants.
• Conducted diligent follow-ups with patients to
monitor progress and address any concerns
throughout the study duration.
• Performed meticulous review of patient charts and
pathological results to maintain high-quality data
integrity.
• Spearheaded Data Collection and Analysis,
translating complex information into actionable
insights.
• Compiled and presented detailed Study Reports,
highlighting key findings and recommendations for
future research.