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Clinical Data Manager

Boston, Massachusetts, 02118, United States
December 25, 2018

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• Highly-dedicated Clinical Data Manager with 6 years of experience in independently managing multiple phase I, II and III clinical trials for drugs, medical devices, and biologics from study startup to closeout.

• Expertise in maintaining updated databases, designing trial documents, operating clinical data management software, processing clinical trial data, and leading the team to complete tasks within deadline.

• My greatest strength is my experience in clinical development combined with my knowledge of project management, which enables me to facilitate successful completion of projects. EDUCATION

Master of Science in Project Management, Northeastern University, Boston Dec 2018 Master of Science in Clinical Research, Cranfield University, U.K. Sep 2011 Bachelor of Science in Bio-technology, Mangalore University, India May 2009 INDUSTRY EXPERIENCE

Clinical Data Manager at Cognizant Ethicon, Johnson & Johnson – New Jersey, USA Jul 2017 – Mar 2018

• Led clinical studies on medical devices and biologics from start-up to database lock.

• Developed and updated data management documents such as Data Management Plan, Data Validation Specifications, Data Entry Guidelines, CRF Completion Guidelines, and Case Report Forms for 2 Phase II, 1 on-going paper-based study, and 1 start-up study on medical devices and biologics.

• Collaborated with the clinical team to develop the protocol for 1 start-up study.

• Trained and supervised clinical data vendors that increased productivity, quality and timely delivery of projects.

• Developed 500 quality edit checks specifications for a phase II trial and performed UAT as per the validation plan.

• Conducted eCRF testing before study Go-Live and during study migration.

• Created and maintained study reports using BOXI and BO4 tools.

• Performed data review, validation, database QC, and all data cleaning activities for all on-going and start-up studies.

• Reviewed and revised all documents for Trial Master File.

• Implemented plans for data processing within established timelines based on project needs. Achievements: ‘Encore’ award in recognition of a special achievement for going above and beyond to ensure that the project had a live database in record time.

Clinical Data Manager (Clinical Research) at Cognizant Technology Solutions - Mumbai, India Dec 2014 – July 2016

• Participated in end to end clinical data management activities from start-up to database lock.

• Primary DM for multicenter phase I and II clinical trials in the therapeutic area of Oncology.

• Developed eCRF Review Manual, eCRF instructions, annotated CRF, Data Validation Specification document, eCRF Data Standard Document and data entry instructions for phase I clinical trials.

• Generated and reviewed ad hoc listings, reports and quality control documentation to facilitate validation of the clinical database and communicated study metrics to clients and vendors.

• Performed Serious Adverse Event (SAE) reconciliation between safety database and clinical study database.

• Performed data analysis and delivered an error free quality database in accordance with the data management project plan and regulatory standards for phase II clinical trials.

• Conducted teleconferences with clients and led project status meetings with the project manager and clinical team. Achievements: ‘Ace of Rookies’ award for rapid and swift climb from learning concepts to execution.

‘Wow’ award for outstanding performance.

Clinical Data Manager (Clinical Research) at TATA Consultancy Services (TCS) - Mumbai, India May 2012 – Dec 2014

• Responsible for phase III clinical trial which was conducted in 18 countries with 25,000 subjects in the therapeutic area of cardiovascular diseases.

• Led the Monitor Issue Log and data manager mailbox team and resolved 2000 pending data issues in the Monitor Issue Log by coordinating with study monitors around the globe.

• Processed external data and performed external vendor data reconciliation, serious adverse events reconciliation, lab reconciliation, query management and user acceptance testing (UAT).

• Collaborated with clinical data coordinators at different sites, statisticians, coding leads, project lead, study specific programmer to facilitate the timely closure of discrepancies.

• Supervised and trained project members and conducted knowledge sharing sessions (KSS) for the team. Achievements: ‘Champion League’ award for successful completion of the clinical study.

‘Star of the Month’ award for outstanding performance. Trainee Clinical Data Management Executive at Vedic Life Sciences Pvt. Ltd. - Mumbai, India Jan 2012 – May 2012

• Performed data entry and data validation of 2500 Case Report Form’s for multicenter clinical studies (paper studies) on Ayurvedic medicines.

• Conducted user acceptance testing (UAT) to assure screen design matches protocol and edits are programmed and operating as intended.

• Retrieved and maintained CRFs in-house, updated data management logs and generated data clarification forms.

• Co-ordinated with CRAs, project managers, coders and medical writers to fasten the query management process. SKILLS:

Clinical Data Management: Electronic Data Capture Systems - InForm 4.6 and Medidata RAVE 2.1 Computer Software: Proficient in MS Office (Advanced Excel, Word, Power Point, Outlook, Project)

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