SITI BALKEES STN HAMEED SULTAN

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, sponsor SOPs, EC/IRB, Protocol, Site Monitoring Plan and associated documents.
• Maintained communication with Study Sites and internal personnel regarding the status of budgets, contracts and any other contract-related documents
• Served as the internal consultant on study budgets with respect to investigator payments, develop and update training documentation and conduct group training as necessary
• Collaborated with Ethics Committees, Institutional Review Boards and Country Regulatory Agencies (Competent Authorities) to ensure protocol amendment authorizations/approvals are obtained
• Forecasted submission/approval timelines and ensure they are achieved; provide contingency plans to mitigate impact if forecasted timelines are not reached, and escalate issues as soon as identified
• Ensured accuracy and completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.

-Oversaw the start-up process for clinical trials, including site selection, initiation, and preparation of study materials.
- Communicated with Study Sites and internal staff regarding the status of budgets, contracts, and other contract-related documents.
- Acted as the internal consultant for study budgets, focusing on investigator payments, creating and updating training materials, and conducting group training as needed.
- Worked with Ethics Committees, Institutional Review Boards, and Country Regulatory Agencies (Competent Authorities) to secure necessary protocol amendment authorizations and approvals.
- Projected submission and approval timelines, ensuring adherence and developing contingency plans to address any delays, escalating issues promptly when identified.
- Verified the accuracy and completeness of Trial Master File (TMF) documents during start-up and conducted a Quality Control (QC) review of files before transferring them for maintenance and filing in the TMF.

-Responsible for the successful management of the site right through site selection to close-out, in accordance with the clinical monitoring plan.
-Remote monitoring of trials conducted in India
-Ensuring the integrity of clinical data by maintaining the site tracking records in accordance with the study protocol and GCP guidelines

• Successfully registered three products under traditional category
  with National Pharmaceutical Regulatory Agency (NPRA)
  Supervised registration of products registration under Therapeutics
  claim (Botanical Drug)
  Well trained in ISO 17025 & GMP guideline
  Prepare quaterly reports & present the progress of clinical trials to
  Ministry of Agriculture (MOA)
  Support the Investigational New Drug (IND) submission to USFDA and
  follow through from submission to approval
  Manage and update the ClinicalTrial.gov portal for updating and
  responding to the queries