Renuka Kutikuppala
Vijayawada
Summary
Highly skilled Clinical Data Management Professional with 6.5+ years of experience in Clinical Research industry specializing in Feasibility, site identification, and Study Start up. Proficient in RAVE EDC and other clinical data management systems including IL2, Zelta, Viedoc, IBM, and Inform. Demonstrated expertise in complex administrative tasks, regulatory compliance, and data accuracy.
Overview
9
9
years of professional experience
Work History
Svc Desk Support Analyst 1
IQVIA and its Affiliated Companies
04.2022 - Current
- Complete appropriate role specific training to perform job duties
- Understanding the purpose and benefits of RAVE EDC system and identifying the roles that participate in RAVE EDC and benefits of the process over the traditional data collection process
- Dealing with IL2, RAVE, Zelta, Viedoc and Inform studies
- Performing tasks using Infolink, ORACLE AND eCOS
- Building a study in database and performing data base lock after completion of the study
- Providing and revoking access to respective studies in Infolink, iMedidata, Zelta and Inform to Site and sponsor staff
- Participate in process initiatives and look at innovative ways to increase quality, service delivery, and value added for the Site Support function
- Making steady progress in terms of self-development as per Individual Development plan
- Appropriate knowledge transfer thorough effective sessions or workshops
- Identifying process of improvement which focus on gaining efficiency / productivity, improving quality, reduction in TAT, bringing in best practices, implementation of new tools, etc
- Providing training to the new hires for RAVE and IL2 and Zelta
- Working on Salesforce and Service now and Inbox
- Creating tickets as per the respective platforms (IL2,sFTP-Service Now) RAVE, Zelta, Inform, Viedoc- Sales Force.
Site Support Specialist II
IQVIA and its Affiliated Companies
09.2019 - 03.2022
- Complete appropriate role specific training to perform job duties
- Understanding the purpose of RAVE EDC system and identifying the roles that participate in RAVE EDC
- Identifying the benefits of the RAVE EDC process over the traditional data collection process
- Entering and managing clinical trail data using eCRFs
- Dealing with IL2,RAVE,IBM,Inform studies
- Performing tasks using DocuSign and Infolink
- Building a study in database and performing data base lock after completion of the study
- Providing and revoking access to respective studies in Infolink,iMedidata and Inform to Site and sponsor staff.
Site Support Specialist
Technosoft
02.2018 - 09.2019
- Perform RAVE, IL2, IBM,Inform activities
Clinical Process Associate-2
IQVIA and its Affiliated Companies
06.2016 - 11.2016
- EDC (IP releasing activities) : Verification/Review of clinical trial essential documents like IRB/IEC approvals, GCP/ GCP compliance, composition of bodies, meeting type, clinical trial agreements, IB, protocol, 1572, investigator and sub investigator CV, experience, previous clinical trial experience, licenses to practice it, affiliation with the trial sites, GCP trainings and accreditation and regulatory approvals, ICF checking, subject materials, FDF, EU FDF, import license, export license, central labs, local labs certifications, lab ranges and cv of lab directors based on country requirements as well as sponsor requirements, based on verification planning site initiation, start up, holding or releasing IP to sites
- Clinical Handover
- E-TMF filing
- Process Management: CTMS Assist with completion of relevant Clinical Trial Management System (CTMS) fields, databases, tracking tools, timelines and project plans with project specific information
- Working on e-TMF filling procedure
- Deliver best value and high-quality service
- Supported multiple clinical trials, across diverse therapeutic areas for successful conclusion and provided technical oversight when required
- Completed appropriate role-specific training to perform job duties
- Performed assigned administrative tasks to support team members with project execution (examples of such tasks include but not limited to running system reports, maintaining minutes of meeting, preparing and distributing status reports, creating and maintaining study documents, etc.) Updated and maintained systems within project timelines and as per project plans
- Establish and maintain effective project/ site communications
- Create and maintain relevant project documents and Ensure accurate completion and maintenance of internal systems, databases, tracking tool sand project plans with project specific
Clinical Process Associate-1
IQVIA and its Affiliated Companies
12.2015 - 06.2016
- Complete appropriate role-specific training to perform job duties
- Perform assigned administrative tasks to support team members with project execution (examples of such tasks include but not limited to running system reports, maintaining minutes of meeting, preparing and distributing status reports, creating and maintaining study documents, etc.) Assist in updating and maintaining systems within project timelines and per project plans.
Clinical process Trainee
IQVIA and its Affiliated Companies
06.2015 - 12.2015
- Complete appropriate role-specific training to perform job duties
- Under supervision, perform assigned administrative tasks to support team members with project execution (examples of such tasks include but not limited to running system reports, maintaining minutes of meeting, preparing and distributing status reports, creating and maintaining study documents, etc.) Under supervision, assist in updating and maintaining systems within project timelines and per project plans
Skills
- Feasibility
- Site identification
- Study Start up
- Clinical trial data management
- RAVE EDC
- IL2
- Zelta
- Viedoc
- IBM
- Inform
- Complex administrative tasks
- Regulatory compliance
- Data accuracy
- Infolink
- ORACLE
- Access management
- Training
- Salesforce
- Service now
- Ticket creation
- User Account Management
- Support Services
- Helpdesk operations
- Training and coaching
- Activity Planning
- Remote Support
- System Administration
- Technical assistance
Language( S)
- I am fluent in both spoken and written English and Telugu, with basic proficiency in Hindi and Kannada
Currentmembershipsinprofessionalorganizations
- Quintiles
- IQVIA Biotech
Clienttestimonials
- Renuka is an excellent and consistent performer. Despite challenges, she delivers high-quality work. Her team spirit and leadership skills are commendable.
- Renuka has been carrying out her tasks as per expectations. She is on top of her work when access to resources is requested. She is very good to communicate with and always accessible.
- Renuka often makes suggestions for process changes that no one else has noticed. She adjusts and evaluates priorities constantly, is efficient with time, and carries a big workload.
- Renuka would do well in a leadership role. She stays engaged in bettering processes and shares valuable input to resolve unseen issues. Her training methods are understandable and easy to follow.
- Renuka displays leadership behavior consistently among the teams. She steps up to take charge when needed and shows leadership skills daily with minimal effort.
Publications, Doctoralthesis
- Preliminary Phytochemical Investigation and IN-VITRO Antioxidant, Antimicrobial and Cytotoxic Activities on Ipomoea quamoclit (Leaves and Stems) - World Journal of Pharmaceutical Research, 2015
- Investigation of Phytochemical Profile and Antibacterial Activity of Leaf Extract of Prosopis juliflora DC - 2012
Formaleducationalhistory
- 12/2014, Sri Sai Aditya Institute of Pharmaceutical sciences and research, India, Mpharmacy, Pharmacology, Completed
- 11/2012, Pydah college of pharmacy, India, B-pharmacy, Pharmacy, Completed
- 03/2008, Sri chaitanya junior college, India, Intermediate, Bi.P.C, Completed
- 03/2006, 3rd BN APSP EM High School, India, 10th standard, SSC, Completed
Timeline
Svc Desk Support Analyst 1
IQVIA and its Affiliated Companies
04.2022 - Current
Site Support Specialist II
IQVIA and its Affiliated Companies
09.2019 - 03.2022
Site Support Specialist
Technosoft
02.2018 - 09.2019
Clinical Process Associate-2
IQVIA and its Affiliated Companies
06.2016 - 11.2016
Clinical Process Associate-1
IQVIA and its Affiliated Companies
12.2015 - 06.2016
Clinical process Trainee
IQVIA and its Affiliated Companies
06.2015 - 12.2015
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