Mandeep Kaur Email & Phone Number

Ottawa, On, Ca

Ottawa, Ontario, Canada

Canada

Handled data abstraction of Lung cancer, Renal cell cancer, Head and neck cancer, breast cancer, lymphoma (Oncology)EMR Learning Specialist.• Provide Project Oversight and Leadership for Clinical Deliverable.• Quality – Training & Development, Quality Assurance (QA) and Quality Control (QC)• Medical chart review/ Review patient files in database and data abstraction from EMRs, deal with ICD 10-CA and CCI, review of SAE reports, Lab reports, Imaging, biopsies, biomarkers, reconciliation of SAE and medical history listings.• Assign diagnostic and procedure codes to I/P, SDS, ER, and Clinic records using ICD 10-CA and CCI • Provide support and training on our EMR applications and assist in ePRO documentations.• Data management and data quality assurance• Review of patient charts, billing details and Prepare safety slides all studies as per sponsor specifications and present during safety calls

•Responsible for the line-management of individuals within a team as well as a project team.•Act as Study Team Lead for 20 projects and support the appropriate Clinical Data Management (CDM) team(s) in the reconciliation of SAEs across safety and trials databases.•Contributes to the review of Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms.•Responsible for study start-up activities, quality check during conduct of the study and electronic archival after data base lock.Compile pre-approval submissions (NDS/ANDS) and post-approval submissions (SNDS, SANDS, NC, PDC-B) for biologics/brand/generic drugs and CTAs.•Well versed with regulations and guidelines e.g. ICH GCP, schedule Y, EMA and FDA. •Review study protocols, Case report forms, LSD, manual lab listings (central and local labs) and raise queries on EDC platforms (Medidata, Inform), RAVE, and SureSource portal.•Responsible for patient enrollment approval in clinical trials and review of clinical laboratory data to Identify potentially significant trends or shifts in laboratory results based on specific guidelines• Managed all trial components (start-up to database lock) and all phases of clinical trials (I to IV)• Set up new projects, utilizing project-specific procedures, working in conjunction with the Sponsor/IQVIA Medical Advisors, Central laboratory project manager, and IQVIA clinical project manager. Ensure that set-up is consistent with standard protocol and maintain the integrity of laboratory support services • Assisting with participant recruitment and informed consent activities• Liaising between the study team members, Medical Services Dept., the sponsor-designated laboratory and with the Project Team• Supported the activities of QA auditors during clinical surveillance and ensure completion of follow-up activities on schedule and support audit preparation & Corrective Action / Preventative Action preparation for local related issues.

Bangalore

• Oversaw the development and maintenance of an Analytical, Competitive and Dynamic Clinical Trial interface Platform for Cardiovascular and Metabolic indications clinical trials.• Contributed to the Clinical Trial interface by development of parameters related to the therapeutic area.• Undertook Clinical trial data analysis, index and update the database, advise the data management staff on trial parameters, database designs, and validation of critical data.• Meticulously did the Statistical and competitive analysis of clinical trial results and recorded changes.• Analyzed clinical trial protocols for the Patient segment involved Inclusion, Exclusion criteria, safety, and efficacy end points in the trials as well as in public domains like Clinicaltrial.gov, ANZ clinical trial registry, ISRCTN registry, Pub med, Journals and trial results from abstracts of various conferences.• Analyzed results for completed and terminated trials by secondary research that describes safety and efficacy outcomes of the trials. Developed indication and non-indication specific detailing for specific disease trials.• Analyzing top drug companies to assess their existing and pipeline products and performing analysis on how drugs work, Mechanisms of Action of the drugs. Charted the adverse events, adverse drug reactions and SAE’s related to the clinical trials.

Post Graduation In Clinical Research, Dentistry

Bds, Dentistry

Cbse Board