Bilal A.

About Bilal A.

Experienced Clinical Research Associate with 6 years of experience in Clinical Operations holding a graduation degree in Pharmacy from Mumbai University.I have worked on trial indications such as Infectious disease, Breast Cancer, Lung Cancer, Type 2 Diabetes Mellitus, Asthma, Chronic Obstructive Pulmonary Disorder, Androgenetic Alopecia, Crohn\'s Disease and Genetic Disorder.I am proficient in various clinical trial software and have hands-on experience on the Global Clinical Trial Systems.Moreover, I possess excellent communication and interpersonal skills, which allows me to establish strong relationships with investigators, study managers, and other key stakeholders.

Experience

1. Clinical Research Associate 2 - Fsp Roche

   IQVIA

   May 2025 — Present · Thane, IN

   1) Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. 2) Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. 3) Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. 4) Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. 5) Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. 6) Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF); verify that the Investigator\'s Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements. 7) Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. 8) Collaborate and liaise with study team and liaise with study team members for project execution support as appropriate. 8) If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. 9) If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Education

• University of Mumbai

  Bachelor of Pharmacy - BPharm, Pharmacy

  2015 — 2019

• Sree Narayana Guru High School

  SSC, Biology/Biological Sciences, General

  2002 — 2012

• Sree Narayana Guru High School

  HSC, Higher Education/Higher Education Administration

  2012 — 2014