Senior Manager, Global Surgical Safety - Edwards Lifesciences - Irvine, CA
(2022-05)
- Oversee safety activities RESTORE, COMMENCE, COMMENCE Pulmonary, INVIVITY and MOMENTIS studies.
- Developed Safety processes and work instructions for various trials and implemented the process.
- Led the study start up activities for MOMENTIS, TRIBLAZE-PAS, TRIBLAZE-STS, CLAARITY, AUTUS studies including finalizing the AE form, DD form, CEC form and CEC charter working with cross functional teams and CEC members.
- Worked with Cloudbyz vendor to develop the Sponsor assessment forms for AE and DDs.
- Worked with Clinical IT, Cloudbyz vendor and data management to develop AE report, DD report and CEC reports.
- Daily review of AEs, DDs for Safety assessment for SAE, USADE, end point events, and potential complaints.
- Reviewed and analyzed weekly aggregate safety reports, monthly review of events along with AE reporting rates per sites.
- Developed periodic AE rates review and presented the results to upper management.
- Helped to develop patient summaries, echo reports, echo and AE alert email notifications for reporting to Complaints Handling team.
- Helped to develop complaints reporting guidelines.
- Reviewed source documents and prepared CEC packets for CEC adjudication.
- Planned, reviewed and presented events/data to CEC and to DSMB committees.
- Developed Safety sections for Annual periodic reports and narratives to DSMB.
- Assisted in developing cross functional RACI (Responsible, Accountable, Consulting, and Informed) document to identify the workflow and responsibilities.
- Developed training materials and train Edwards and site personnel and safety committees on safety reporting and appropriate support documentation.
- Worked with vendors in planning, charter development, training CEC and DSMB committees.
- Advised study team on Safety reporting process and requirements.
- Advised Safety officer in China Inspiris study on Safety reporting of events, understanding of endpoint definitions, AE codes, and reportable events as needed.
- Assisted in budget planning and forecasting.
- Managed direct reports and provided guidance and trainings as needed.
Medical Safety Monitor - Abbott - Santa Clara, CA
(2017-12 - 2022-05)
- Managed safety activities for clinical trials of medical devices including, MitraClip, and Absorb stent trials according to Standard Operating Procedures, ICH guidelines and GCP.
- Worked as lead safety monitor for Triluminate Pivotal (TriClip device), XIENCE 90, XIENCE 28G, XIENCE 28 USA, COAPT (MitraClip device), COAPT CAS, ABSORB III/IV, MitraClip EXPAND, SHIELD II (HeartMate Percutaneous Heart Pump), Cephea Early Feasibility study (Cephea Mitral Valve System), and RESOLVE MR (Tendyne Mitral Valve System) studies which included AE review and coding of events.
- Provided inputs on Clinical trial design, develop safety sections of study protocols, and regulatory submissions.
- Completed Safety sections for annual progress reports, primary endpoint reports and other reports as needed.
- Represented safety in internal and external audits.
- Represent safety in cross-functional and core team meetings.
- Worked on developing AE forms, adjudication forms, edit checks, perform user acceptance tests before the release of applications.
- Developed Safety plans, CEC charters and DSMB charters for the studies.
- Conducted CEC and DSMB meetings.
- Reviewed adjudicated events by CEC for accuracy and consistency.
- Reviewed and approve risk sections in ICF, write narratives for adjudicated endpoints.
- Coordinated with IQVIA Safety, IQVIA OGM, LAAN, Baim Institute and Cardiac Research Foundation vendors on various issues including narratives, SDE evaluation, CEC adjudications, and CEC meetings.
Consulting Clinical Safety Monitor - Abbott Vascular - Santa Clara, CA
(2017-02 - 2017-12)
- Oversaw safety activities for clinical trials of medical devices including, MitraClip, and Absorb stent trials according to Standard Operating Procedures, ICH guidelines and GCP.
- Worked as lead safety monitor for Short-term DAPT, COAPT, Absorb III/IV studies.
- Coordinated with Novella Safety, Novella OGM, and CRF on a daily basis on various issues including narratives, SDE evaluation, CEC adjudications, CEC meetings, and DSMB meetings.
- Developed Safety plan for various studies.
Consulting Senior Safety Specialist - Novella Clinical Inc - Morrisville, NC
(2015-10 - 2017-01)
- Worked as the lead safety specialist for COAPT, EVEREST II, and ABSORB II clinical trials.
- Responsible for daily review of AEs, SAEs, device relationship and USADE in COAPT, Absorb III, Absorb IV, & Everest clinical trials.
- Created and submitted MedDEV reports and EC reports for AB II, and EC reports for COAPT.
- Responsible for writing and auditing written narratives for COAPT, EVERST II, ABSORB III and ABSORB IV studies.
Consulting Clinical Safety Monitor - Abbott Vascular - Santa Clara, CA
(2014-03 - 2015-10)
- Managed safety activities for clinical trials of medical devices including, Mitraclip, and Absorb stent trials according to Standard Operating Procedures, ICH guidelines and GCP.
- Responsible for daily review of AEs, SAEs, device relationship and UADE in Mitraclip, Absorb Japan, Absorb IV clinical trials.
- Requested source documents, reviewed and edited narratives and reviewed Clinical Events Committee adjudication results for COAPT and ABSORB Japan Trials.
- Reviewed CEC adjudication results for ABSORB II, ABSORB III, and ABSORB EXTEND trials.
- Developed new specs for EDC and completed end user testing for Mitraclip and Absorb studies.
- Provided safety inputs in team and critical variables meetings.
Director of Academic Affairs - Eagle Gate College - Salt Lake City, UT
(2011-07 - 2013-08)
- Guided Academic department as per the mission, vision, and values of Eagle Gate College.
- Managed annual operating and capital budgets.
- Hired, trained, and supervised program administrators and faculty.
- Developed and operationalized the department goals in alignment with the College goals and mission.
- Managed program directors for Personal Fitness Program, Massage Therapy, Medical Assisting, Dental Assisting, Nursing, Medical Billing and Coding, Paralegal, and Graphic Web Design program.
- Conducted faculty evaluations, faculty training, coordinate teaching schedules, implementation and enforcement of policy and procedures for the College.
- Extensive experience in student advising, counselling, and held student events such as new student orientations and student recognition events.
- Ensure compliance with accreditation standards of ACICS accrediting agency.
Director of Education - Fortis College - Salt Lake City, UT
(2010-01 - 2011-06)
- Provided leadership to Academic department by facilitating, directing, and coordinating operational activities and programs relative to the daily operations.
- Supervised Medical Assisting, Dental Assisting, Medical Insurance Billing and Coding, Heating, Ventilation, Air-conditioning and Refrigeration, programs.
- Developed and built new programs as per the standards of state and national agencies.
- Hired, trained, evaluated faculty and Program Chairs for various programs.
- Responsible for developing, reports, planning, compliance and accreditation.
- Managed an annual operating budget of $2 million.
- Supervised and advised students, Program Chairs, LRC Manager, Registrar, Student and Career services director, and faculty.
Medical Programs Chair - Bright Star Education Group - Arvada, CO
(2009-04 - 2009-10)
- Conducted extensive market studies on the need of new healthcare programs at various campus locations.
- Guided and advised program directors develop healthcare programs.
- Advised on developing and modifying school policies on admissions, attendance and grading.
Director - Institute of Medical Education - San Jose, CA
(2004-12 - 2009-03)
- Helped to raise revenues from start up to $8 million in 4 years.
- Initiated 7 new health care programs and helped to increase student population to 500 within a span of 3 years.
- Responsible for hiring, educating, and evaluating faculty of various programs.
- Managed and guided program directors including Vocational nursing, Nursing Assistant, EMT, Phlebotomy, Medical Assisting, Diagnostic Medical Sonographer programs.
- Started as an Instructor for a start-up vocational school and was promoted to the position of Director.
- Assisted in getting school accreditation and Federal financial aid.
- Developed policies in compliance with WASC Accrediting agency to meet the compliance requirements.
Physician - St. Joseph's Hospital - India
(1999-10 - 2000-10)
Department of Medicine and Cardiology
- Managed outpatient and inpatient departments including staff on a day-to-day basis.
- Treated and managed Medical and Cardiac emergency patients in ER.
- Conducted number of clinical procedures including EKG, Cadio-pulmonary resuscitation, Pleural tap, Bone Marrow Aspiration, tissue biopsies, and Lumbar Punctures.
- Developed and promoted adherence to clinical standards of care.
- Trained and educated staff about certification and annual compliance.
- Promoted safety and security in the facility by conducting regular safety inspections and monitoring the work environment for potential hazards and maintenance issues.
Physician - Chord Road Hospital and Chhaya Nursing Home - India
(1997-01 - 1999-10)
Department of Cardiology
- Managed outpatient clinic and inpatient wards for the Department of Cardiology.
- Daily monitored and treated patients admitted in inpatient wards and ICCU.
- Conducted and assisted in relevant cardiac tests and procedures such as EKG, Stress test, Echocardiography, venipuncture, cardio-pulmonary resuscitation etc.
- Evaluate diagnostic tests, such as x-ray, electrocardiogram and lab tests (Cardiac enzymes values) to identify abnormalities.
- Reviewed and interpreted patient care information, discharge summaries, and operation reports to assess quality care issues and identify opportunities for improvement.
- Assisted the Department Chair with hiring, planning and budgeting for the clinics.
Medical Officer/Physician - Department of Public Health - Maldives
(1996-12 - 1997-12)
- Managed and treated outpatients and inpatients of health center.
- Exemplified and promoted positive patient relations. Optimized healthcare delivery processes to streamline an efficient patient flow.
- Was responsible for monitoring, evaluating, and reporting diseases and healthcare issues and conducting needs assessments, planning and implementing interventions.
- Conducted clinical research on irrational use of antibiotics and their effects on infectious diseases for United Nations.
- Collected and studied the lab tests, diagnoses, and various clinical procedures conducted on patients visiting hospitals.
- Collected information on types of antibiotics prescribed, patient demographics, dosage and adverse & side effects.
- Interviewed patients, collected, analyzed, and evaluated clinical data visiting the hospital.
