Sri Ramanujam

Healthcare and clinical research professional with experience supporting clinical operations and study activities across Phase I–IV. Experienced in clinical documentation, Trial Master File (TMF) and Investigator Site File (ISF) management, study start-up, regulatory documentation, cross-functional coordination, vendor support, and inspection readiness. Working knowledge of ICH/GCP guidelines and FDA and EMEA regulations, with hands-on experience using EDC/clinical systems and document platforms including IMPACT, SharePoint, and Veeva Vault.

Therapeutic-area experience includes immunology, oncology, respiratory disease, and CNS.

Study Start-Up Clinical Study Administrator - ASTRAZENECA

(2024-02)

• Support planning, coordination, and execution of clinical studies in accordance with study protocols, SOPs, ICH-GCP, and applicable regulatory requirements.
• Coordinate day-to-day clinical trial activities and provide administrative support to Clinical Operations and study teams throughout the study lifecycle.
• Maintain essential clinical trial documentation and ensure study records are complete, accurate, current, and readily accessible.
• Support study start-up activities, including collection and tracking of required documents, site information, and study materials.
• Coordinate communication and follow-up with cross-functional teams, clinical sites, vendors, and internal stakeholders to support timely study deliverables.
• Track study milestones, action items, timelines, and outstanding documentation; escalate issues and delays to appropriate team members.
• Assist with preparation, review, filing, and quality control of clinical study documentation and support inspection and audit readiness.
• Supported coordination and administration of clinical studies from start-up through execution and close-out.
• Maintain accurate study information in clinical trial systems and databases and identify documentation gaps for resolution.
• Collaborate with CRAs, Clinical Study Managers, project teams, and other stakeholders to support efficient study execution.

Clinical Trial Specialist - FATHOM LIFE SCIENCES, NJ - NJ

(2021-10 - 2024-01)

• Supported coordination and administration of clinical studies from start-up through execution and close-out.
• Collected, prepared, reviewed, and tracked documents for regulatory authority and ethics committee application processes.
• Served as a local administrative point of contact and coordinated with investigators, external service providers, CRAs, and local study teams.
• Set up, maintained, and closed local eTMF and ISF documentation, supporting ICH/GCP compliance and local requirements.
• Contributed to production and maintenance of study documents, ensuring template, version, language, and quality requirements were met.
• Created and imported clinical-regulatory documents into ANGEL according to the Global Document List and supported submission-ready standards for regulatory publishing.
• Maintained study tracking and communication tools including IMPACT and SharePoint and supported users with system processes.
• Supported study contracts, investigator payments, study materials, meetings, audits, regulatory inspections, document distribution, and archiving.
• Performed quality assurance activities for paper and electronic TMF documents, including indexing, uploading, approval workflows, and document management.

Dentist - SREE SAI DENTAL HOSPITAL - HYDERABAD & VIKARABAD, INDIA

(2018-03 - 2021-03)

• Coordinated community engagement initiatives, health education campaigns, and outreach programs.
• Conducted comprehensive assessments and collaborated with multidisciplinary teams to develop individualized care and education plans.
• Maintained accurate documentation of client interactions, interventions, and progress in accordance with organizational requirements.
• Led more than 20 oral hygiene campaigns and educated patients on preventive dental care, plaque control, treatment options, and tobacco cessation.
• Served as a Dental Advocate and supported outpatient and inpatient operations, oral health emergencies, and patient care.
• Participated in health missions and government health programs at Ananthagiri and the Rural Health Centre of Vikarabad.

Master - Public Health - University of New Haven (2023-05)

Post Graduate Diploma - Clinical Research and Management - CLINI INDIA (2021-02)

Bachelor - Dental Surgery - Dr. NTR University of Health Sciences (2017-03)