Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Extracurricular Activities
Hobbies and Interests
Training
Disclaimer
Personal Information
Work Availability
Timeline
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Akash K

Akash K

Bangalore

Summary

Adept in leveraging advanced data management tools like Medidata Rave and demonstrating strong leadership qualities, I significantly contributed to clinical study successes at IQVIA. Recognized for exceptional problem-solving skills and the ability to mentor team members, I excel in fast-paced, multicultural environments, ensuring project deliverables meet stringent timelines and quality standards.

Overview

5
5
years of professional experience

Work History

Associate-Clinical Data Science

Eli Lilly
Bangalore
11.2023 - Current
  • Providing insights for trail setup during the startup phase.
  • Oversighting fully outsourced projects to different vendors.
  • Performing quality checks on vendors' tasks.
  • Collaborating with vendors and ensuring all the deliverables are completed as per the timeline.
  • Coordinating meetings to understand the risks and status of the assigned projects.
  • Contributing to process improvements.
  • Leading three projects independently and achieving the deliverables.
  • Ensuring all the documentation is current and filled out as per organization requirements.
  • Coordinating with other line functions, like medical and statistics teams, for required support.
  • Providing status updates to line management on an ongoing basis.
  • Working in the VEEVA electronic data capturing tool.

Clinical Data Specialist

IQVIA
Bangalore
01.2020 - 10.2023
  • I have worked as an operational lead for more than five studies related to thalassemia, respiratory issues, gastrointestinal infections, ovarian carcinoma, and ulcerative colitis.
  • I had experience in all three phases (Study start-up, Conduct, and Study close-out).
  • Worked on Medidata Rave, Inform, IBM CD, and OCR DC.
  • Handled 6 studies as Operations Lead and participated in over 1 study lock and around 3 interim data locks.
  • Write data clarifications as directed by the Data Operations Coordinator.
  • Resolve data clarifications, as per SAS specifications.
  • Meet personal project objectives, as assigned by the manager.
  • Understand and comply with core operating procedures and working instructions.
  • Understand, provide input to, and comply with all applicable sections of the Data Management Plan.
  • Develop and maintain good communications and working relationships with the CDM team.
  • I have experience primarily in conduct and closeout activities, as well as several hands-on experiences in startup activities in clinical data management.
  • Discrepancy Management (Listing Review, Query Management).
  • External Data Reconciliation (Vendor Reconciliation).
  • Performing SAE reconciliation.
  • Manual review for critical forms.
  • Freezing and Locking Activities.
  • Track the progress of clinical studies and the financial tracking of the study in DM operations level, ensuring the project meets timelines and quality expectations.
  • Creating custom reports as per sponsor requirements.
  • Conduct basic and advanced data reviews of datasets.
  • Edit Check Specification Creation and Testing for SAS Listings.
  • Conduct quality control procedures.
  • Resource management and allocation of study activities.
  • Escalate problems to the attention of the Data Team Lead, or Project Manager.
  • Understand basic database structures.
  • Created client-specific weekly and monthly status reports.
  • Participated in database locks and interim analysis.
  • I was one of the key team members for the locking activity.
  • Recognized for hard work and flexibility, twice received the 'Spotlight Award'.
  • Mentored team members for the reviewer role and operational lead roles.

Education

P.G.Diploma - Clinical research

Clini India Clinical Research Institute
12.2020

Bachelor of Pharmacy -

Sree vidyanikethan college of pharmacy
Tirupati
12.2019

Skills

  • Timely completion of activities
  • Flexible in adopting innovative technologies
  • Effective communication skills, interacting positively, and establishing relationships based on respect, leadership quality, positive mental attitude, and commitment to excellence
  • Comprehensive problem-solving ability
  • Zeal to learn new things
  • Ability to work with minimal supervision in a fast-paced environment
  • Can work in a multicultural and different global environment
  • Medidata Rave
  • IBM CD
  • Inform 61
  • OCRDC
  • IBM-CD
  • Veeva
  • Microsoft Office
  • Vendor reconciliation
  • SAE reconciliation

Accomplishments

  • Created client specific weekly and monthly status reports.
  • Participated in Database locks and Interim analysis. Key team member for the locking activity.
  • Recognized for hard work and flexibility twice with the 'Spotlight Award'.
  • Mentored team members for Reviewer role and Operational Lead roles.

Languages

  • English
  • Tamil
  • Telugu
  • Hindi

Extracurricular Activities

Responsible for several Team Building Activities in IQVIA. Helped in conducting Events in IQVIA INDIA. Key Team member in a group called 'Fungenesis'. Presented DM NEWSLETTER in Reviewers summit in IQVIA INDIA. Mentored Team members for Reviewers for reviewer role and operations lead role summit in IQVIA INDIA.

Hobbies and Interests

  • Writing Tamil poetry
  • Listening to Music

Training

  • Completed DM school organized by IQVIA.
  • Participated in Learn to Excel training conducted by IQVIA.
  • Attended the DOC (Data Operations Coordinator) summits and Trainings organized by the company.
  • Attended the Reviewer summits organized by IQVIA.
  • Eli Lilly training for Data management professionals.

Disclaimer

I hereby declare that the information given above is genuine to the best of my knowledge.

Personal Information

  • Date of Birth: 05/20/97
  • Nationality: Indian
  • Marital Status: Married

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Associate-Clinical Data Science

Eli Lilly
11.2023 - Current

Clinical Data Specialist

IQVIA
01.2020 - 10.2023

P.G.Diploma - Clinical research

Clini India Clinical Research Institute

Bachelor of Pharmacy -

Sree vidyanikethan college of pharmacy

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Akash K