Project Clinical Research

Ms. AMRIT JUMBO - M.SC, B.SC (Bioanalytical Sciences)

#***, ** ******** ****** ****, Mississauga, ON - L5R 0E5, Canada M: +1-365-***-****

Email: ac8o7o@r.postjobfree.com LinkedIn

Nationality Status: Canadian PR

Targeting Positions In:

MEDICAL COMPANIES/LABS/HOSPITALS (CLINICAL RESEARCH & LAB, IT DATA MANAGEMENT)

I am a capable professional with 2 years of experience in clinical research. I am able to manage end-to-end Clinical Trial Operations for complex project(s), sites and project teams by performing complex processes to meet target SLAs using analytical procedural skills. I have expertise in the analysis of samples using HPLC, HPTLC, GC, IR, UV-VIS techniques. I am able to perform and assist in experiments and prepare the required buffers and reagents. I am dedicated and committed to adhere and perform all laboratory functions in accordance with Standard Operating Procedures (SOPs) and safety guidelines of the organization. I am able to multi-task and work as a team player with excellent interpersonal skills.

WORK EXPERIENCE

IQVIA (QUINTILES) PTE LTD. Oct 2017 – May 2018

Clinical Process Associate-2/ SUSAR Liaison Lead (SLL) – Centralized Monitoring Service (CMS)

Job Duties:

• Work as SUSAR Liaison Lead for all active Biogen studies, for SUSAR management, being the main point of contact in the

form of the SUSAR enquiries mailbox for PPD when they have any queries regarding site contact details, EC contact details etc., providing support to project teams requiring information from PPD, tracking and follow-up of all queries until a resolution is received.

• Approve payments to investigator, institutes and subjects participating in Clinical Trials in accordance with sponsor and

company requirements. Also review Clinical Trial Agreements and CTA amendments to ensure payments are made as per the documented payment terms and schedule. In addition, identify and work with clinical team to follow up on invoice discrepancies.

• Ensure and verify that all SUSARs and CIOMS Reports are tracked in Clinical database (CTMS) indicated as per internal SOP

guidelines.

• Assist Centralized Monitoring Services with process development and keeping up to date with the latest developments, as well as provide training on new developments.

• Assist in assigned project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meet quality and timeline metrics.

IQVIA (QUINTILES) PTE LTD. Apr 2017 – Sep 2017

Clinical Process Associate-I / Clinical Analyst Support (CAS) – Centralized Monitoring Service (CMS)

Job Duties:

• Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines.

• Assist in assigned project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.

• Collect documents from investigative sites during monitoring visit and either file or transfer to RIM for filing.

• Updating and maintaining clinical systems within project timelines; prepare, handle, distribute, file, and archive clinical

documentation and reports; review of study files periodically for accuracy and completeness; maintenance of tracking systems.

• Establish and maintain effective project/ site communications.

• Participate in document management (creation, review, maintenance, storage, as applicable)

• Collaborate with the project lead/team members in creation/review of study documents.

IQVIA (QUINTILES) PTE LTD. Oct 2016 – Mar 2017

Clinical Process Trainee - Clinical GDN

Job Duties:

• Perform assigned administrative tasks to support team members with project execution (examples of such tasks include but

not limited to running system reports, maintaining minutes of meeting, preparing and distributing status reports, creating and maintaining study documents, etc.)

• Assist in updating and maintaining systems within project timelines and per project plans.

• Assist the clinical team in the preparation, handling, distribution and filing of clinical documentation.

• Collects documents from investigative sites during monitoring visit and either files or transfers to RIM for filing.

Clinical Trial Experience (On the Job):

Study Phase: Phase 1b/2 Phase 3

Indication: Malignant Melanoma Ulcerative Colitis

Special Population: Diagnosis of Advanced Cutaneous Melanoma Elderly

Drug Class: Biologics Immunosuppressive Agents

# of Patients: 250 1385

Role: Clinical Analyst Support Clinical Analyst Support

RECOGNITION AND REWARDS

• Received BRAVO Award from Head of Department and Line Manager for my Dedication, Teamwork, Quality, Efficiency and

Ownership at IQVIA

FORMAL EDUCATION

• M.Sc in Bioanalytical Sciences GNIRD, Mumbai University, India Jun 2016

Overall ranking 2nd out of 25 in the college. Achieved CGPA of 6.87 on a 7-point scale

• B.Sc in Bioanalytical Sciences GNIRD, Mumbai University, India Jan 2014

Overall ranking 1st out of 30 in the college. Achieved CGPA of 6.85 on a 7-point scale

CERTIFICATIONS

• Certified training in "SPSS Statistics (Statistical Package for the Social Sciences)" course from Khalsa College, University of

Mumbai

• Certified training in "Sensory Evaluation of Food" from Ruia College, University of Mumbai

*Academic and professional references available upon request.

Contact this candidate