MRUDULA RAJASHEKARAN
Kochi
Summary
Post graduate professional with overall 6.7 years of industry experience, which includes 6.1 years of experience in clinical data management with Iqvia and LabCorp drug development, extensively worked with global and referral labs. Operational experience in Data Management (DM) that has spanned the full duration of studies, from study start-up to database lock on various global/multi-national studies (Phase I, II, III) across the globe with experience working on Cardiovascular, Influenza Vaccine-, Insulin-Dependent Diabetes Mellitus (IDDM) and Non-Insulin-dependent Diabetes Mellitus (NIDDM) studies. Within my position as Clinical Data Specialist, I took on/continued the role as a Laboratory (LAB) Specialist. The roles and responsibilities of a Lab Specialist include but are not limited to providing expertise and performing specialized laboratory data management activities as part of a data management team to ensure efficient, quality data management products that meet customer needs. Also have hands on experience in laboratory and medical practices with Manipal Hospitals. Worked in different diagnostic disease findings and have extensive knowledge in the use of different kind of equipment such as gamma counter, spectrometer, densitometer as well as different immunoassays such as radioimmunoassay, enzyme immunoassay and Fluro immunoassay.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Clinical Data Specialist- Data management (Novella Clinical full services)
Iqvia RDS Pvt. Ltd.
06.2022 - Current
- Provide clinical lab data expertise as part of a team to develop and maintain Laboratory Data Management (Lab DM) for the studies awarded to IQVIA Biotech and meets the internal/external client data reporting needs.
- Serve as primary point of contact for lab data management deliverables
- With minimal guidance, manage project timelines and quality issues and identify and justify out of scope
- Unit testing of Lab Module
- Lab Administration Module revisions based on project needs· (i.e. add Analyte Names, Units, Unit Dictionaries, etc)
- Add Analyte Names, Units, Unit Dictionaries, etc)
- Creation of the Lab ID Worksheet/Protocol Specific Normal Ranges Spreadsheet based on CRF specific lab forms
- Issue queries and review query responses with the highest level of quality based upon the Data Review Plan, Manual Review, Aggregate Checks (DM listings), and Reconciliation (LAB, SAE, ECG, and other vendors)
- Assist with other data reviews for Biostatistics, Medical Review, Sponsor, and other adhoc reports.
- Perform validation of data management system (CRF content & edit checks) and associated DM reports or listings, and change control.
- Provide feedback to other DMs and Programmers to improve the deliverables.
- Create and update DM documentation as directed by the DM lead including Data Review Plan (along with supporting DM documents), CRF Completion guidelines, Data Entry guidelines etc.
- Experience in EDC Rave platform
- Back-up or Primary DM for internal/client team meetings
- Train and mentor junior lab data coordinator and DM staff for lab related activities.
EDR Clinical Data Management Associate (CDM)
Lab Corp Drug development Pvt. Ltd.
05.2018 - 05.2022
- Receive and process data from various global referral or local labs
- Manage internal Calculated Administrative Worksheets globally and collaborate with the Calculation Team and Support peers by sharing technical knowledge and customer service skills; provide coverage for peers as needed globally
- Perform quality checks and validation of results from select external referral laboratories
- Monitor and respond to the email communications including the team distribution list
- Manage training folders and update documentation, review standard operating procedures And other documents update departmental metrics tools and provide monthly reports of Management
- Interact with internal and external teams resolve queries, initiate data changes and provide support and process improvements as needed
- Follow-up on database load, database modification, data lock and project closure notifications
- Request and compile source data for audit requests; present the resulting process, if requested
- Research questions and provide external lab-specific documentation
- Ensure compliance with departmental guidelines and company standards.
Manipal Hospitals
10.2017 - 04.2018
- Organizes work by matching computer orders with specimen labeling; sorting specimens; checking labeling; logging specimens; arranging reports for delivery; keeping work surfaces clean and orderly
- Maintains quality results by running standards and controls, verifying equipment function through routine equipment maintenance and advanced trouble shooting; calibrating equipment utilizing approved testing procedures; monitoring quality control measures and protocols
- Provides physician with information for treatment of patient infection by performing technical procedures for the identification or susceptibility of bacteria, parasites, fungi, and mycobacteria
- Provides test results for patient diagnosis and treatment by operating equipment such as the gamma counter, spectrophotometer, densitometer, and through methods such as radioimmunoassay, enzyme immunoassay, and serological testing
- Maintains patient confidence by keeping laboratory information confidential.
Education
M.Sc. In General Microbiology -
The Oxford College Of Science
B.Sc. in Microbiology - undefined
Kannur University
High School Diploma -
GHSS MATHIL
Payyannur03.2012
Skills
- Decision-making capabilities
- Project management abilities
- Conflict resolution techniques
- Data management expertise
- Clinical Research
- SOP compliance
- Problem-solving abilities
- Discrepancy management
- Team Collaboration
- Multitasking
- Time management abilities
Languages
English, Tamil, Malayalam, Hindi, Kannada
Memberships Awards
- Participated in National Life Science Seminar Conducted in SN College Kannur.
- Was an active member of National Service Scheme in 2013- 15
- Trained in Computer Aided Drug Designing
- Trained in HACCAP (Hazard analysis critical control
- Trained in Microsoft Excel, MS Outlook, MS Excel, Power Point
Personal Information
Date of Birth: 02/26/94
Projects
Successfully completed and presented project on topic "STRAIN IMPROVEMENT FOR THE PRODUCTION OF PECTINASE ENZYME USING INDUCED STRESS".
Disclaimer
I do hereby declare that the particulars of information and facts stated in above are true, correct and complete to the best of my knowledge and belief.
Accomplishments
- Level 3 Ace award -2018-2019 successful Database lock.
- DSSM People Deal Award Spring Semi-Finalists for category- passion for work.
- Got appreciation from the client Acerta (IYA05780) for successfully locking for Interim analysis.
Certification
• Trained in Computer Aided Drug Designing
• Trained in HACCAP (Hazard analysis critical control
• Trained in Microsoft Excel, MS Outlook, MS Excel, Power Point
• Certificate course for clinical research.-Coarsera.
Additional Information
Personal Information
Date of Birth : 26- Feb-1994
Languages Known : English, Tamil and Malayalam, Hindi, Kannada.
: C1 Second floor “KaveriPermanent Address
Apartment", Thoppil Family lane, Marottichodu, Edappally, Kochi 682024Declaration
I do hereby declare that the particulars of information and facts stated in above are true, correct and complete to the best of my knowledge and belief.
Timeline
Clinical Data Specialist- Data management (Novella Clinical full services)
Iqvia RDS Pvt. Ltd.
06.2022 - Current
EDR Clinical Data Management Associate (CDM)
Lab Corp Drug development Pvt. Ltd.
05.2018 - 05.2022
Manipal Hospitals
10.2017 - 04.2018
M.Sc. In General Microbiology -
The Oxford College Of Science
B.Sc. in Microbiology - undefined
Kannur University
High School Diploma -
GHSS MATHIL
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