Tejas Thomas Email & Phone Number

Australia

Australia

• Medical Writing: To review the scope of task, negotiate and create timelines, organise document reviews, and primary point of communication. To develop early phase trial documents including protocol, Investigators.
• Drug Safety and Pharmacovigilance: Liaise with study team, Investigators, site staff, medical monitors, and regulatory services, as applicable. Case processing, query generation/follow-up, and reporting of safety.
• Regulatory: Primary point of contact between organization, local regulatory authority and other government departments for clinical trial applications, safety, and reporting. Submission of clinical trial safety.

Bengaluru, Karnataka, India

Bangalore

Bengaluru Area, India

• To write clinical documents including clinical study protocol, clinical study report, patient narratives, etc., and quality control for format and consistency.
• To manage timelines for assigned tasks and address client requests and project needs.

India

• Drafting regulatory submission documents like Clinical Study Protocol (CSP), informed consent form (ICF), Assent form (AF), Clinical study report (CSR), patient narratives, etc.
• Reviewing and carrying out QC with an eye for detail in documents such as Protocol Synopsis, ICF, CSR, clinical trial registry (CTR), common technical document (CTD), European clinical trial database (EudraCT).
• Working directly in coordination with clients, statisticians, project managers and other departments.
• Mentored and performed training sessions for new staff and support them with requisite guidelines, work procedures and other relative topics.
• Ensure compliance, addressed issues/concerns, resolved client queries.

Bangalore

• Handled global and local phase III cardiovascular and endocrinology studies.
• Ensured compliance with GCP, study protocol and regulatory guidelines in study conduct.
• Performed site feasibilities and site initiation visits.
• Developed study specific logs, forms and monitoring plan.
• Compiled and maintained trial master file.
• Lead in organizing investigators meeting.

Bangalore

• Assisted Principal Investigator in ICF process, screening patients for study enrollment and randomization.
• Tracking subjects to avoid lost-to-follow-up.
• Performing protocol procedures in detailed and accurate manner including IVRS.
• Maintaining study files, study related communication and correspondence by telephone/fax/email with subjects, IRB, monitors or sponsor and archival.
• Processing and shipping lab collection.
• Ensure timely serious adverse events (SAE) reporting and submission to ECs.

Master Of Public Health - Mph, Public Health

Pursuing a career in public health and policy making. Keen interest in Indigenous Health and primary prevention of chronic health diseases.

Pg Diploma In Clinical Research And Data Management, Clinical/Medical Laboratory Science/Research And Allied Professions

Master Of Science (M.Sc.), Microbiology, General

Bachelor Of Science (B.Sc.), Microbiology, General,