Surya Lekha K
Clinical Data Management
Hyderabad,TS
Summary
Accomplished Clinical Data Management Professional with 5.4 years of experience in Phase I–III oncology trials. Expertise in user acceptance testing, discrepancy management, database lock, and close-out activities. Ensured data quality and regulatory compliance while collaborating with cross-functional global teams. Skilled in Medidata Rave and Veeva, with a strong understanding of SAE reconciliation, lab data management, and ICH-GCP guidelines.
Overview
10
10
years of professional experience
Work History
Clinical Data Associate III
Syneos Health | Client: Roche
11.2023 - Current
- Managing Phase I/II oncology studies involving lymphoma and carcinoma indications.
- Performing data review, discrepancy management, SAE reconciliation, UAT, and lab reconciliation activities.
- Supporting database cleaning, quality review, and early database closure activities.
- Collaborating with cross-functional teams to ensure timely and accurate study deliverables.
- Participating in Data Review Team Meetings and Clinical Trial Team Meetings from a DM perspective.
- Monitored data quality metrics, identifying discrepancies and implementing corrective actions to maintain data accuracy.
- Collaborated with cross-functional teams to streamline clinical trial processes and improve data collection efficiency.
- Developed and maintained documentation for data management, facilitating seamless audits and inspections.
Clinical Data Associate II
Syneos Health | Client: Roche
04.2021 - 03.2022
- Performed QC activities for lab data, ensuring accuracy and compliance with study specifications.
- Conducted User Acceptance Testing (UAT) and generated test data based on SDTM standards.
- Managed SAE reconciliation and lab reconciliation procedures.
- Supported development and maintenance of DMPs, validation specifications, and SOPs.
- Managed eTMF activities, study metrics, and quality review processes.
- Led data validation efforts to ensure compliance with regulatory standards and enhance data integrity.
- Collaborated with cross-functional teams to streamline data collection processes, improving efficiency and accuracy.
- Reviewed clinical trial data for discrepancies, mitigating risks and ensuring alignment with protocol requirements.
- Mentored junior team members on best practices in data management and compliance, fostering skill development.
Clinical Data Associate
Syneos Health | Client: Roche
01.2018 - 03.2021
- Reviewed study-specific Clinical Data Management Plans and ensured compliance.
- Performed edit checks, discrepancy management, and validation review activities.
- Conducted internal QC checks against CRFs and DCFs.
- Managed query handling, reconciliations, and database review activities.
- Supported interim analyses, dry runs, and data cut activities.
- Coordinated with global teams and external CROs for study deliverables.
- Developed Data Transfer Agreements (DTAs) for oncology vendors.
- Tracked study metrics and data management deliverables across multiple studies.
Hospital Pharmacist Intern
ESI Hospital
08.2016 - 08.2018
- Engaged in clinical rounds and patient care activities.
- Conducted medication reconciliation and monitored adverse drug reactions to ensure patient safety.
- Conducted comprehensive medication reviews to ensure safety and compliance with established protocols.
- Conducted medication reconciliation and monitored adverse drug reactions.
- Collaborated with healthcare professionals to optimize medication therapy, resulting in improved patient outcomes.
- Participated in clinical rounds and patient care activities.
Education
Doctor of Pharmacy (Pharm D) -
MLRIP
Hyderabad, India03-2018
Skills
- Clinical data management
- Data quality review
- Discrepancy management
- User Acceptance Testing
- Database Lock Activities
- Query Management
- Data Cleaning
- Lab reconciliation
Accomplishments
- Received multiple Spotlight Recognitions from study leads and molecular leads.
- Awarded “Alpha Player” for exceptional contribution during critical timelines.
- Recipient of PQS (Passion Quality Speed) Award – Syneos Health
Timeline
Clinical Data Associate III
Syneos Health | Client: Roche
11.2023 - Current
Clinical Data Associate II
Syneos Health | Client: Roche
04.2021 - 03.2022
Clinical Data Associate
Syneos Health | Client: Roche
01.2018 - 03.2021
Hospital Pharmacist Intern
ESI Hospital
08.2016 - 08.2018
Doctor of Pharmacy (Pharm D) -
MLRIP
Expertise
• Therapeutic Area Expertise: Oncology Clinical Trials (Phase I/II Studies)
• EDC & Clinical Systems: Medidata Rave, Veeva Vault, Veeva eTMF, SharePoint
• Technical Proficiency: Microsoft Office Suite (Excel, Word, PowerPoint, Outlook)
• Regulatory & Compliance: ICH-GCP Guidelines and Clinical Data Management Standards