Rupali Phadke

FAQ About Rupali Phadke

• What is Rupali Phadke's address?

  Rupali Phadke is located at
  Thane, Maharashtra, India

• What is Rupali Phadke's job title?

  Rupali Phadke is a
   Total 13 years of experience with 11 years of experience in core CDM Domain having hands-on experience on databases: Medidata Rave 5.6.4, Medidata Classic Rave 2019.1.3, Oracle Clinical, and Inform 5.0.  Proficiency in Team management, Client Management, Planning, Communication and Data Management activities.  Successfully locked mega trials and handled a team of 13 team members. Study Start up Activities  eCRF development - Protocol, Budget review, eCRF finalization, Screen UAT, Review protocol amendment, perform post production changes  Data Management Plan development – Creation and finalization of data management plan. Refer budget and work order to identify scope of work – number/type of external data reconciliation involved and frequency of data review, Coding-AE reconciliation frequency, dictionary details etc.  eCRF Completion Guidelines development – Creation and finalization of eCRF completion guidelines.  Data Validation Specification development – Creation of edit check specification, field level checks, manual listings specification, SAS listing specification and testing, edit checks testing, data validation specification document finalization. Edit check go live activities.  Data Import Agreement Study Conduct activities  Discrepancies Review  Manual Listing Review  Protocol Deviation Listing review  External data reconciliation Study close out activities  Ensure final round of data activities .  Ensure Source Data Verification completed as per the monitoring plan.  Ensure DM Quality Review is completed for assigned eCRFs.  Ensure freezing, is completed for all subjects. PI Signature is obtained.  Timely completion of the database lock procedures.  TMF Filing – complete Veeva Vault/PPG filing in a timely manner. Project management –  Lead and Monitor the progress of all data management activities for the study to ensure that study timelines are met.  Regular follows up with sponsors, site monitors, medical coding and statistical programming team to ensure smooth functioning of a study (I.e. Email/ Study Status meetings)  Informing risks and contingencies to the internal-sponsor team which helps in study progress  Mentoring new associates in the team.  Monitor team performance, work assignment.  Participate in knowledge sharing sessions whenever required.  Share study team members work feedback with line manager whenever required. Ppd

• What industry does Rupali Phadke currently work in?

  Rupali Phadke currently works in the
  Ppd

• What is Rupali Phadke's area of expertise?

  Rupali Phadke specializes in
   Total 13 years of experience with 11 years of experience in core CDM Domain having hands-on experience on databases: Medidata Rave 5.6.4, Medidata Classic Rave 2019.1.3, Oracle Clinical, and Inform 5.0.  Proficiency in Team management, Client Management, Planning, Communication and Data Management activities.  Successfully locked mega trials and handled a team of 13 team members. Study Start up Activities  eCRF development - Protocol, Budget review, eCRF finalization, Screen UAT, Review protocol amendment, perform post production changes  Data Management Plan development – Creation and finalization of data management plan. Refer budget and work order to identify scope of work – number/type of external data reconciliation involved and frequency of data review, Coding-AE reconciliation frequency, dictionary details etc.  eCRF Completion Guidelines development – Creation and finalization of eCRF completion guidelines.  Data Validation Specification development – Creation of edit check specification, field level checks, manual listings specification, SAS listing specification and testing, edit checks testing, data validation specification document finalization. Edit check go live activities.  Data Import Agreement Study Conduct activities  Discrepancies Review  Manual Listing Review  Protocol Deviation Listing review  External data reconciliation Study close out activities  Ensure final round of data activities .  Ensure Source Data Verification completed as per the monitoring plan.  Ensure DM Quality Review is completed for assigned eCRFs.  Ensure freezing, is completed for all subjects. PI Signature is obtained.  Timely completion of the database lock procedures.  TMF Filing – complete Veeva Vault/PPG filing in a timely manner. Project management –  Lead and Monitor the progress of all data management activities for the study to ensure that study timelines are met.  Regular follows up with sponsors, site monitors, medical coding and statistical programming team to ensure smooth functioning of a study (I.e. Email/ Study Status meetings)  Informing risks and contingencies to the internal-sponsor team which helps in study progress  Mentoring new associates in the team.  Monitor team performance, work assignment.  Participate in knowledge sharing sessions whenever required.  Share study team members work feedback with line manager whenever required.

• Which languages does Rupali Phadke speak? 

  Rupali Phadke speaks the following languages:
  No languages available.

• Which industries has Rupali Phadke previously worked in?   

  Rupali Phadke has prior experience in the following industries:
  Iqvia , Syneos Health , Syneos Health , Tata Consultancy Services , Cognizant Technology Solutions Hiranandani Powai Mumbai , Caliber Point

• What is Rupali Phadke’s work experience?  

  Rupali Phadke has the following professional experience:
  Ppd , Iqvia , Syneos Health , Syneos Health , Tata Consultancy Services , Cognizant Technology Solutions Hiranandani Powai Mumbai , Caliber Point .

• How can I find Rupali Phadke on LinkedIn?  

  You can view Rupali Phadke’s
  LinkedIn profile at LinkedIn URL.

• What are Rupali Phadke’s work email addresses?  

  Rupali Phadke’s work email addresses are
  [email protected] .

• What company does Rupali Phadke work for?  

  Rupali Phadke works at
  Ppd