Travelling
Suwathi Subramanian
Associate Clinical Data Coordinator
Bengaluru
Summary
Seeking a challenging position in the field of Clinical data management, where my existing skills can be utilized, my fast learning and the ability to take on new challenges can be used, and offers me professional growth while being resourceful, innovative and flexible for the welfare of mankind.
Overview
2
2
years of professional experience
5
5
years of post-secondary education
3
3
Languages
Work History
Associate Clinical Data Coordinatior
IQVIA
07.2022 - Current
- Performed manual data review, QC and write data clarifications along with Discrepancy Management, SAS Listings.
- Experienced in Vendor reconciliation (Lab data & IVRS), SAS listings, Query Management, e SAE reconciliation.
- Expert in data handling and study hypothesis, well-versed in cGCP and FDA standards and regulation and knowledgeable in therapeutic indications.
- Run and review data management metrics report.
- Performed data review activities in EDC, Query management. Participated in study migration activities, snapshot activities and data lock activities.
- Expert in post-lock activities such as e-Archival, Hyperlinking QC specialist.
- Hands on experience on working on e-TMF, performed activities such as uploading full data PDFs to e-TMF
- Knowledge of e-TMF guidelines.
- Performed QC for post lock activities.
- Mentored juniors for QC and post-lock activities
- Clinical phases worked on: Phase 1,2 and 4.
- No of studies worked on data management: 4.
- No of studies performed eArchival- 21.
- No of studies performed Hyperlinking QC- 4.
- No of studies worked for eTMF- 5
Education
Master of Science - Biochemistry
Mount Carmel College
Bangalore 06.2019 - 05.2021
Bachelor of Science - Biochemistry
PSG College of Arts And Science
Coimbatore 06.2016 - 05.2019
Skills
Teamwork
Active listening
Problem solving
Communication
Adaptability
Critical thinking
Time management
Interpersonal
Professionalism and excellence
Professional Summary
- Strong knowledge in Drug Development Process and Clinical Trials.
- Strong knowledge in various SAS formats and functions.
- Strong knowledge and handling experience of multiple Case Report Forms (CRF).
- Strong knowledge on post-lock activities such as e-Archival, Hyperlinking QC specialist.
- Flexibility and Adaptability to changing environments.
- Keen desire and willingness to learn new technologies and processes.
- Extremely passionate about SAS and Life Sciences .
- Demonstrated capacity to work with dedication and involvement.
Therapeutic Expertise
- Therapeutic area: Oncology, Neurology and Bone.
- Database tools : Medidata Rave
- Ms office : word, powerpoint and excel
Interests
Painting
Declaration
I hereby declare that the above mentioned information is true to the best of my knowledge and belief.
Timeline
Associate Clinical Data Coordinatior
IQVIA
07.2022 - Current
Master of Science - Biochemistry
Mount Carmel College
06.2019 - 05.2021
Bachelor of Science - Biochemistry
PSG College of Arts And Science
06.2016 - 05.2019
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