Experience

Avance Clinical

• Australia
• Biotechnology Research
• 100 - 200 Employee

• Clinical Data Manager

  • Feb 2022 - Present

  Preparation of Data Management Plans.· Preparation or review of Edit Check Document.· Development and review of Case Report Forms (CRFs) and completion guidelines in line with the database and protocol.· Preparation of clean and erroneous dummy data.· Database Validation (testing data entry screens and edit checks using dummy data).· Provide training to site, Sponsor and other staff in the use of eCRF systems.· Resolution of Quality Assurance (QA) comments.· Perform data review and cleaning of data collected during the trial.· Receipt of external data & transfer of data to internal/external parties.· Raise queries in the database while conducting cleaning activities.· MedDRA / WHO-DD Coding and review.· Perform Quality Control on study data prior to lock.· Act as Data Project Manager including interaction with Clinical Project Manager, interact with site/ client/ external vendors, perform overall Project Management and timeline management.· Training of Clinical Data Associates in Avance Clinical processes and Data Management tasks.· Provide support in filing and other administrative tasks in order to maintain Data Management document systems up-to-date.· Maintain effective communication with other members of the business.· Other duties as directed by Line Management or delegate.



CMAX Clinical Research

• Australia
• Research Services
• 100 - 200 Employee

• eSource Developer and Senior Data Assistant

  • Jul 2020 - Feb 2022

  Leading eSource Studies at the clinical trial site. eSource Database Development and eQC. Discrepancy management. Leading eSource Studies at the clinical trial site. eSource Database Development and eQC. Discrepancy management.



The Royal Melbourne Hospital

• Australia
• Hospitals and Health Care
• 700 & Above Employee

• Research Assistant

  • Sep 2018 - Jun 2019

  KEY RESPONSIBILITIES:- Liaising with medical professionals to work and provide valuable inputs in the study. Support to identify and recruit study participants at specific clinic times. Assistance with clinical data collection. Collation of completed Case report form and inform consent form at each of the Sydney sites. Clinical Data entry KEY RESPONSIBILITIES:- Liaising with medical professionals to work and provide valuable inputs in the study. Support to identify and recruit study participants at specific clinic times. Assistance with clinical data collection. Collation of completed Case report form and inform consent form at each of the Sydney sites. Clinical Data entry



Cognizant

• United States
• IT Services and IT Consulting
• 700 & Above Employee

• Clinical Data Analyst

  • Oct 2010 - Jun 2018

  Study Development:• Plan all the study development activities as per timelines decided by clients.• Perform online and offline data review of annotated trial design and data report specification documents.• Preparation of Case report form completion instructions (CCI), CCI Tagging and Linkage.• Develop edit checks specifications or Data validation specifications and reports writing the specification.• Perform the user Acceptance Testing to deliver robust and clean data.• Perform quality checks of edit check specifications, report review specifications and user acceptance testing to ensure correctness.Study Conduct:-• Perform Query Management to clarify and improve the quality of the data.• Perform activities related to database/reports revision and maintain documentation for the same.• Perform and review IVRS batch loading activities.• Perform medical coding activity on clinical data.• Write and run the SQLs to review the major data.• Perform data management activities on the assigned project in a timely and efficient manner.• Generate and review reports, listings to check the data consistency.• Participate in clinical data review meetings.Study Closeout: -• Initiate and update pre-lock and lock checklist.• Perform final documentation activities and reports as listed in pre-lock and lock checklist to archive in the client-specific environment. • Run reports/listings as per pre-lock and lock checklist.• Maintain documents in client network and assure the eTMF status of each and every document.• Maintain electronic documentation as per list provided client for study closure.• Accountable for responding to post Database lock questions /queries.Key Achievements:• Promoted to Data analyst in Oct-2011• Received Star of the Month Award in Sep-2015.• Received Star Team of the Month Award in Aug-2015.• Received Star of the Month Award in Mar-2016.• Received Star of the Month Award in Dec-2016.



IGATE

• Information Technology & Services
• 700 & Above Employee

• Clinical Data Management

  • Dec 2006 - May 2008

  Key Responsibilities:-• Involved in Phase II and Phase III clinical trials (Vaccine trials, Oncology trials, diabetes and respiratory disorder trials).• Actively involved in study start-up activities; Prepared project specific data validation plan and edit check specifications to achieve clean data.• Raising queries or clarification and resolving them after a satisfactory response from a clinical study site• Handling and archiving of original CRF files, data clarification forms.• Responsible to maintain the confidentiality of the important documents for audit and regulatory purposes.• Insert clinical data in a customized database from case report form.• Perform double data entry of clinical data from case report form.• Perform verification of double data entry to ensure the compliance with original CRF data.• Perform database audit as part of Quality Control.• Trained and mentored the new team members for clinical data entry activities.• Involved in preparation and implementing of SOPs for clinical data entry process. Key Achievements:• Promoted to Paper Flow information in-charge in July-2007.