Devendra Zope

Experience

• 

  Excel Life Sciences Pvt. Ltd.

  May 2015 - Feb 2018

  Clinical Research Coordinator

  Trials Assisted: 1. Chronic Non-Infectious Posterior Uveitis Phase III. (Indian)2. Clinical Evaluation of IP on Corneal Staining in Indian Subjects with Dry Eye.3. Chronic Non-Infectious Posterior Uveitis Phase III. (Global)4. ME Associated with Non-Infectious Uveitis.Principal Working: • Identification of potential investigators/Sites and ongoing review/development• Conduct of ICH GCP,ICMR/DCGI Guidelines, Study Specific Training on a regular basis at the sites• Scan patients data and short listing of patients• Help the investigator in screening patients• Assisting investigators in the IC Process, coordination and management of laboratory samples, courier and follow-ups of lab reports• Drug accountability and dispensing at the site• IVRS/IWRS for patient’s randomization in randomized studies• IP management, dispensing, temperature monitoring and accountability• Ensure compliance of project specific schedule of activities• Ensure compliance of SOPs (both internal & external as applicable)• Preparation, attendance and follow-up of monitoring• Completing CRF entry with minimal error.• Preparation, attendance and follow-up of Audit• Trial closeout: preparation, attendance and follow-up; forwarding the necessary information of site closeout to all concerns• Manage & Develop the Investigators in the respective region • Verify the accuracy and validity of data entered in databases; correct any errors • Submit reports & research findings to internal & external customer• Compiling verifying information of data.Project Specific:• PI/site identification, assess manpower need & infrastructure capabilities, ensure timely enrollment• Interaction with Sites• Provide feedback/inputs to operations, regarding the progress of a studyOTHER:• Interaction with other team members/sites involved across studies• Managing the reports, trackers regarding the progress of a study• Highlighting any red flag issues & ensure timely/ appropriate resolution. Show less

• 

  IQVIA Asia Pacific

  Feb 2018 - Mar 2019

   Responsible for the site management, data review and/or query resolution. Serve as in-house expert on assigned sites (for patient enrollment, protocol compliance, study site staff issues, IRB and regulatory document status, data status and other site matrices). In collaboration with the assigned (field) CRA, performs routine site management activities, including site training, assistance with site questions, patient recruitment and retention management, study supplies management, resolve and document outstanding site issues/action items. Site Communications to remind and/or assist data entry, query resolution, open site issues resolution. Review the quality and integrity of patient data at assigned sites through the remote review of electronic CRF data.  Perform data listing download and review. To prepare data set to be review on site for CRAs prior to monitoring visit. Ensures timely transmission of clinical data from assigned study sites and works with sites to resolve data queries. Assist with final data review and query resolution through database lock; inclusive of patient profile and data listings review. PEW initial review prior to Medical Monitor review. Perform risk-based quality trial management to identify access, control, communicate and review study risk. Assist with the development of risk assessment thresholds and recommended actions for key performance indicators for a study. Therapeutic Area Experience: Oncology. Indications: DLBCL, Ovarian Cancer, Prostate Cancer, T-Cell Lymphoma. Systems/Tools handled: Medidata RAVE, i-Medidata, i-Mednet, Express Bioclinica, J-Review, CTMS, several eTMFs and IWRS/IVRS systemsCTM SUPPORT/CMOA Activities:Follow-up MV reports, TS and/or ES review Show less

  • Clinical Process Specialist

    Oct 2018 - Mar 2019

  • Senior Clinical Process Associate

    Feb 2018 - Sept 2018
• 

  Covance

  Apr 2020 - now

  Senior Centralized Study Associate