Swaranjali Pawar

About Swaranjali Pawar

An accomplished Clinical Research Data Management professional with 15+ yrs of experience. I possess a strong project management, people management, and team management skills.• Into Clinical Research – Data Management since 2005.• Currently associated with PFIZER HEALTHCARE INDIA PVT. LTD. as Senior Data Manager since July 2019. Working on Covid-19 Lightspeed studies.• Worked with CHILTERN INDIA (A COVANCE Company) as Senior Clinical Data Analyst from 2006 – 2019.• Represented CHILTERN INDIA during Investigator Meet (IM) held at Mumbai, Udaipur, Beijing (China), Colombo (Sri Lanka), and Seoul (South Korea).• While with SIRO CLINPHARM, worked on Pfizer projects using Oracle Clinical version 4.5. In September 2005 promoted as Data Acquisition Officer, in which worked for Lab Normal Ranges for LNR-New London group (Pfizer).• Good knowledge & experience of Oracle Clinical, Clintrial, Clintrace, Biosys, Inform, Datalabs, IBM eCOS, iMednet, Medidata Rave systems, JReview and DMW.• Experienced in End-to-end activities (Set-up, conduct and Close-out), Project Management.

Experience

1. Senior Data Manager

   화이자

   Jul 2019 — Present · Mumbai, IN

   Overall responsible for timely & high quality data review & query management of clinical data. Develop & maintain key data management deliverables used to collect, review, monitor, & ensure the integrity of clinical data.Responsibility:• As Lead Data Manager for clinical trials, handling responsibilities of DM activities and Project Management:o Working as Functional Lead for Data Management including primary contact for internal liaison between Data Management, Study Management, Clinical Monitoring, and other functional groupso Working on four Covid-19 Lightspeed studies.o Resource managemento Selection and application of data acquisition standards,o Ensures delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulationso Provides project specific trainingo Database design and CRF customisation (including specification documentation and testing of clinical data collection tools, both CRF and non-CRF, using an EDC system and/or other data collection systems),o development and maintenance of the Data Management Plan, Data Transfer Specifications, Data Review Plan, Tracking Logs, Daily summary reports o Data Management metrics reporting,o database release, and submission related activities• Maintains proficiency in Data Management systems and processes through regular training• Independently lead the daily DM activities and allocate study DM resource in the appropriate way.• Training• Plan & create necessary documentation to support internal and external audits; participate in such audits• Responsible to achieve the study DM milestone on time with good quality.• Working on TMF documentation & content QC to support inspection & submission readiness activities. • Ensure operational excellence: application of standards, data acquisition, data review, data cleaning, query management, e-data processing, data access & visualization.

Education

• University of Mumbai

  M.Sc.

  2000 — 2002

Skills

• CRO
• Clinical Trials
• Gcp
• Pharmacovigilance
• Clinical Research
• Regulatory Affairs
• Clinical Development
• Pharmaceutical Industry
• Sop
• Ich-Gcp
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• Clinical Data Management
• Oncology
• Edc
• Ctms