Naga Vardhini

Having 10+ years of experience in Clinical trials/Data management, with extensive knowledge in Preclinical, clinical trials and data management activities.

To work in an organization that gives me a chance to update my knowledge, enhance my skills and to be a member of a team that excels in working towards the growth of the organization. My objective is to continuously add value to my place of work and to my work in the chosen field.

Experience

2016-06 - 2019-09: Worked for Autoimmune Therapeutic area as a Clinical Data Manager in Cognizant Technology Services, Hyderabad

2015-08 – 2016-06: Worked as Senior Research Associate in Syngene International Limited

2011-07 – 2015-07: Worked as a Research Associate-2 at Aurigene Discovery Technologies (Dept. of pharmacology) Hyderabad

Responsibilities

• Develop and maintain good communications and working relationships with CDM team
• Handling RBSE (Risk Based Study Execution) studies
• Meet objectives as assigned in Oncology and Neuroscience studies.
• Understand and comply with core operating procedures and working instructions
• Write and resolve data clarifications
• Provide key inputs to Clinical Trial team meetings.
• Serve as a Data Operations Coordinator for three protocols.
• Serve in a leadership role in data management task with guidance.

Responsibilities when served as a Data Reviewer

• Review clinical data as per SOP, protocol, and study specific guidelines.
• Provide timely and professional ongoing management of clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s). 
• Issue queries within the clinical database for missing, inconsistent, illegible, or erroneous data; follow queries to resolution and close-out in OCRDC/Medidata Rave systems respectively.
• Assist with study start up activities, including but not limited to test CRF mock-up and entry, database screen testing, and edit check testing.
• Assist with developing and maintaining study edit checks, eCRF specifications, Clinical Outcome Assessments.
• Assist in basic database and edit check testing activities in OCRDC/Medidata Rave systems respectively.
• Perform all clinical data cleaning, including, but not limited to - external data cleaning, such as lab data review and Questionnaire Data reconciliation 
• Perform Serious Adverse Event reconciliation
• Assist with clinical database closeout activities, including but not limited to listing review, audit activities, etc.
• Assist in assessing potential issues/data trends to supervisor/project team member in a timely manner and follow issues through resolution.
• Interact with various Data Management and other functional area colleagues, including, but not limited to: Programming, Clinical, Project Management, Safety, Medical Coding, site personnel.
• Develop and track timelines and ensure CDM project milestones are met in coordination with the project team.

Masters degree in Clinical Research and Regulatory affairs, with an aggregate of 65%.