Tejaswi Pitta
Hyderabad
Summary
Immensely motivated and dynamic professional with three years of experience in a renowned Contract Research Organization (CRO), where I have been exposed to study setup (clinical trial testing solutions) within the Global Project and Database Management team. Skilled in managing backend clinical trial development, creation/modification of investigator manuals, clinical documentation, clinical data analysis, MS Office 365, AWS, and Power BI. Adept at ensuring compliance with ICH-GCP guidelines, and driving project success through effective team leadership, communication, and quality management.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Senior Clinical Project Coordinator
Labcorp Laboratories India Private Limited
Bangalore
03.2024 - Current
- Compliance check of SOW documents and investigator manuals.
- Mentored and trained new hires for all regions served as a Subject Matter Expert (SME).
- Establish and maintain all project documentation, including all files, records, and reports, according to the scope of work and SOPs, and upload them in the TMF (Trial Master File).
- Developed and implemented performance improvement strategies and plans to promote continuous improvement.
- Worked as a workload dealer for the Global Study Operations team, and delivered projects on time or ahead of schedule. My role as a workload dealer for the GSO team involved managing work activities to finish projects before due dates.
- Worked as an Internal Quality Controller for the Global Study Operations team. My role as a QC'er for the GSO team is to review the projects and to identify and rectify any errors before final production.
Clinical Project Coordinator
Labcorp Laboratories India Private Limited
Bangalore
04.2022 - 02.2024
- Managed to accomplish work assignments to meet the project expectations of clients and external stakeholders.
- Create and modify investigator manuals used in clinical trials.
- Maintain global communication and coordination with all central laboratory services units regarding service definitions and changes for global processes.
- Learned new skills and applied them to daily tasks to improve efficiency and productivity.
- Centralized designers and global managers provide appropriate service levels.
- I worked as a corrections team member for the GSO team. As a corrections team member, my role is to repair mistakes in accordance with the GSM and SLD criteria. Essentially, serving as a quality control specialist for the team.
- Monitoring of clinical research and conducting daily operations using tools such as Workfront, Gopher, and other related software for site management.
- Managed escalations by performing quality event investigations for internal and external stakeholders.
- Interact with internal teams and global stakeholders, i.e., with the Clinical Database.
Education
Master of Pharmacy -
Balaji College of Pharmacy
Anantapur06-2023
Bachelor of Pharmacy -
RIPER
Anantapur06-2021
Skills
- Microsoft Office 365
- Power BI
- Veeva Vault (eTMF)
- Gopher
- Exacta
- Workfront
- Time management
- Leadership and teamwork
- Problem solving
- Data entry
- Report generation
- Vendor management
- Communication and coordination
Career Objective
Seeking a challenging and innovative career in project management and clinical research at a professional organization that is conducive to learning and growing my professional, as well as personal, skills to their fullest potential, thereby directing my future endeavours as an asset to the organization.
Accomplishments
- Received ACE award level 1 for process excellence for delivering projects on time, achieving 100% quality and TAT
- Awarded Zenith of the Month (10/01/23) for exemplary performance
Certification
- Base SAS certified
- Completed an advanced PG Diploma in Clinical Research, Pharmacovigilance, Clinical Data Management from Clinosol Research Private Ltd.
Hobbies and Interests
- To actively develop skills in the areas of clinical trials, good clinical practice (GCP), and project management at the industry level
- Keen to be involved in team-building activities and employee engagement
- Active sports person and team player
Languages
Telugu
First Language
English
Proficient (C2)
C2
Hindi
Upper Intermediate (B2)
B2
Academic Projects
- M.pharmacy - COMPARATIVE ANALYSIS OF RAMIPRIL AND TELMISARTAN: EVALUATING INFLAMMATORY MEDIATED RESPONSE AND ANTIHYPERTENSIVE EFFICACY IN ACUTE CORONARY SYNDROME PATIENTS.
- B.Pharmacy - “MIXED MICELLES” for improved delivery of anti-cancer agents.
Timeline
Senior Clinical Project Coordinator
Labcorp Laboratories India Private Limited
03.2024 - Current
Clinical Project Coordinator
Labcorp Laboratories India Private Limited
04.2022 - 02.2024
Master of Pharmacy -
Balaji College of Pharmacy
Bachelor of Pharmacy -
RIPER
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