Project Specialist with 4+ years of experience in clinical trial operations. Expertise includes 2 years as Associate Safety Specialist and 1 year 7 months as Associate Programmer. Proven ability to manage project timelines and ensure compliance with regulatory standards.
Overview
5
5
years of professional experience
Work History
Project Specialist-RTSM, Operations - GSS Project Support Services
Signant Health
Hyderabad
11.2023 - Current
Collaborated with internal clinical trial teams and sponsors to meet all FDA compliances and regulations. Managed project processes with multiple software tracking tools (JIRA, SQL, Adobe, AQT) and executed technical and clinical functions by the study protocol and according to standard operating procedures (SOPs).
Contributed to the successful execution of project tasks under the guidance of the Associate Project Manager and/or Project Manager. Effectively managed assigned responsibilities throughout the project lifecycle, ensuring timely and accurate completion.
Prepared and reviewed study manuals and guides.
Resolved reconciliation and data integration issues through retrigger activities.
Worked with different tickets from multiple ticketing systems (JSM, PITA, PI, DTPs) and forms (DCF, UCF, OCF).
Supported PM activities, including client-facing and non-client-facing communications.
Contributed to enhancements, UAT setups, and related documentation.
Coordinated with internal and external stakeholders to ensure smooth project activities.
Coordinated across all project phases, ensuring the project plan and deliverables met client expectations.
Multitasking, maintaining schedules, and maintaining compliance with quality deliverables in dynamic environments.
Collaborated with Global Project Management and Global Technical Delivery teams for timely project deliverables.
Oversaw development and approval of study materials, ensuring compliance with Quality Management standards.
Reviewed and monitored study status, risks, resources, and logistics to ensure alignment with the scope of services.
Have an overview of new Change Order creation and supporting Business Development operations.
Successfully executed all startup activities for RTSM (Randomization and Trial Supply Management) studies, ensuring readiness and compliance with study protocols and timelines.
Associate Programmer
Clinotica Software Solutions
Hyderabad
07.2022 - 11.2023
Gathered user requirements and performed data screening, cleaning, and integration to ensure accuracy and consistency.
Developed and validated SDTM datasets using SAS programming, including variable derivation based on annotated CRFs and mapping sheets.
Created project-specific macros and organized initial study folders to establish clear study hierarchies and workflows.
Utilized SAS/Base, PROC MEANS, PROC FREQ, and PROC REPORT for statistical analysis and report generation; leveraged SAS ODS for customized outputs in HTML, RTF, and PDF formats.
Ensured timely completion of assigned objectives, communicated project updates to team leads, and supported departmental reporting and collaboration efforts.
Associate Safety Specialist
PPD, part of Thermo Fisher Scientific
Hyderabad
09.2020 - 06.2022
Progressed from Initial Reviewer to Quality Reviewer (Sept 2020-Oct 2021) through internal job posting, demonstrating growth and adaptability.
Conducted literature screening to identify Individual Case Safety Reports (ICSRs) and other safety-related findings.
Reviewed case entries for quality, consistency, and accuracy, including peer report evaluations.
Managed receipt, tracking, and validation of ICSRs from various sources (post-marketing, clinical trials, literature) for database entry.
Performed detailed data entry of complex ICSRs, ensuring accurate coding using MedDRA and WHO drug dictionaries, and clear narrative summaries.
Coordinated the conduct of root cause analysis (RCA) and developed corrective and preventive actions (CAPA) for protocol deviations.
Executed self-quality checks prior to workflow progression, maintaining high standards of data integrity and compliance.
Education
Doctor Of Pharmacy -
Vaagdevi Institute of Pharmaceutical Sciences
01.2020
Skills
Clinical research and trial operations
Global project management
Regulatory compliance and data oversight
Team leadership and training
Time management and multitasking
Microsoft Office Suite proficiency
SAS programming
Statistical analysis
Timeline
Project Specialist-RTSM, Operations - GSS Project Support Services
<ul>
<li>Spearhead the management and oversight of the National Bio and Agro-Defense Facility (NBAF) project, a pivotal national asset developed in partnership with the U.S</li>
<li>Department of Agriculture (USDA) and the U.S</li>
<li>Department of Homeland Security (DHS)</li>
<li>Collaborate with USDA and DHS stakeholders to ensure a seamless transition of operations and mission capabilities from the aging Plum Island Animal Disease Center (PIADC) to NBAF, ensuring uninterrupted research, diagnostics, and training essential to national security</li>
<li>Lead the operational endurance phase, validating work processes and laboratory setups to guarantee compliance with the highest safety and biocontainment standards, particularly in biosafety level-4 (BSL-4) environments</li>
<li>Act as the hiring manager, conducting interviews and selecting high-quality employees to ensure the success of both DCA and NBAF</li>
<li>Serve as a subject matter expert pert for the payroll system Paychex, overseeing and approving payroll for 63 officers biweekly while managing paid time off and leave requests to maintain the security posture for the facility</li>
<li>Monitor project milestones, providing critical updates to senior management and stakeholders while ensuring alignment with USDA's mission objectives and federal guidelines</li>
<li>Direct the development and execution of strategic initiatives to facilitate efficient collaboration with federal partners, ensuring all laboratory operations adhere to regulatory requirements set forth by the Federal Select Agent Program (FSAP)</li>
<li>Foster a culture of excellence and professionalism within the team, emphasizing rigorous training, safety compliance, and operational integrity as key components of NBAF's mission to safeguard public health and the nation's food supply</li>
<li>Monitored budgeting activities by tracking expenditures and providing regular updates to management.</li>
<li>Analyzed existing processes within a department or organization in order to identify areas for improvement or increased efficiency.</li>
<li>Implemented quality control measures throughout each stage of a project's lifecycle.</li>
<li>Worked closely with senior managers to ensure that all projects were completed according to schedule.</li>
<li>Conducted research on potential vendors, suppliers, contractors and subcontractors for projects.</li>
<li>Provided administrative support to the Project Manager in order to facilitate successful project outcomes.</li>
<li>Prepared monthly progress reports summarizing key accomplishments achieved since the last report.</li>
<li>Trained junior staff on best practices for managing multiple projects simultaneously.</li>
</ul> at Defense Contracting Activity, LLC<ul>
<li>Spearhead the management and oversight of the National Bio and Agro-Defense Facility (NBAF) project, a pivotal national asset developed in partnership with the U.S</li>
<li>Department of Agriculture (USDA) and the U.S</li>
<li>Department of Homeland Security (DHS)</li>
<li>Collaborate with USDA and DHS stakeholders to ensure a seamless transition of operations and mission capabilities from the aging Plum Island Animal Disease Center (PIADC) to NBAF, ensuring uninterrupted research, diagnostics, and training essential to national security</li>
<li>Lead the operational endurance phase, validating work processes and laboratory setups to guarantee compliance with the highest safety and biocontainment standards, particularly in biosafety level-4 (BSL-4) environments</li>
<li>Act as the hiring manager, conducting interviews and selecting high-quality employees to ensure the success of both DCA and NBAF</li>
<li>Serve as a subject matter expert pert for the payroll system Paychex, overseeing and approving payroll for 63 officers biweekly while managing paid time off and leave requests to maintain the security posture for the facility</li>
<li>Monitor project milestones, providing critical updates to senior management and stakeholders while ensuring alignment with USDA's mission objectives and federal guidelines</li>
<li>Direct the development and execution of strategic initiatives to facilitate efficient collaboration with federal partners, ensuring all laboratory operations adhere to regulatory requirements set forth by the Federal Select Agent Program (FSAP)</li>
<li>Foster a culture of excellence and professionalism within the team, emphasizing rigorous training, safety compliance, and operational integrity as key components of NBAF's mission to safeguard public health and the nation's food supply</li>
<li>Monitored budgeting activities by tracking expenditures and providing regular updates to management.</li>
<li>Analyzed existing processes within a department or organization in order to identify areas for improvement or increased efficiency.</li>
<li>Implemented quality control measures throughout each stage of a project's lifecycle.</li>
<li>Worked closely with senior managers to ensure that all projects were completed according to schedule.</li>
<li>Conducted research on potential vendors, suppliers, contractors and subcontractors for projects.</li>
<li>Provided administrative support to the Project Manager in order to facilitate successful project outcomes.</li>
<li>Prepared monthly progress reports summarizing key accomplishments achieved since the last report.</li>
<li>Trained junior staff on best practices for managing multiple projects simultaneously.</li>
</ul> at Defense Contracting Activity, LLC