Glixy Raju
Birkenhead,United Kingdom
Summary
Experienced clinical research professional with over seven years of experience across clinical data management and study operations. Developed a strong and adaptable skill set through progressive roles within global clinical research environments. Currently working as an Associate Study Manager at ICON plc, UK, supporting end-to-end study activities and contributing to the successful delivery of clinical trials in a regulated setting.
Proven ability to work under pressure while ensuring timely and accurate data delivery in line with client, regulatory, and quality requirements. A confident and effective communicator with the ability to collaborate across cross-functional teams as well as work independently. Highly motivated to continuously expand technical expertise, leadership capability, and industry knowledge.
Overview
9
9
years of professional experience
2015
2015
years of post-secondary education
1
1
Certification
Work history
Associate Study Manager
ICON Plc
, United Kingdom
11.2023 - 01.2026
- Support the Global Clinical Trial Manager (GCTM), Global Early Clinical Development Manager (GECDM), Local Trial Manager (LTM), Regional Clinical Trial Manager (RCTM) or Country Study Manager (CSM) in the delivery of the clinical and operational strategy and assist the execution of clinical trials in accordance with ICH-GCP, standard operating procedures and applicable regulations
- Oversee data management during study phases, collaborating with trial management staff for timely execution.
- Support Regulatory submission and GCP statement review and update
- Collaborate with clinical trial management staff to support the timely execution and monitoring of clinical studies and trial deliverables
- Manage the process for planning and procuring ancillary clinical supplies, including collaboration with BSM and assay groups to coordinate shipment and analysis of clinical biological samples
- Process work requests to Study Management Associate (SMA) team
- Participate in and support study team and cross functional meetings including the preparation of meeting agendas and minutes
- Support inspection readiness activities (e.g. Study History Document / TMF maintenance and review)
- Participate in study planning and set-up activities including vendor management, project management and the coordination of study and implementation plans
- Assist in ensuring that all site and study team members are trained on the conduct of the study and that they understand the study timelines and deliverables; coordinate activities as needed between study team members
- Recruitment and retention activities
- Prepare and communicate regular updates to the study team
- Support and oversee vendor activities and relationships where assigned
- Coordinate study-level Investigational Product arrangements, accountability and reconciliation
Clinical Data Specialist
IQVIA
, India
05.2019 - 09.2022
- Led clinical data management deliverables with strong adherence to ICH-GCP standards.
- Managed and mentored Clinical Data Specialists, ensuring balanced workload and timelines.
- Ensured data accuracy, completeness, and validity across multiple trials including oncology studies and Regeneron trials.
- Ensuring accurate and complete Case Report Form entry during trial execution
- Supported UAT testing, Spotfire and J-Review analysis, and corrective action implementation.
- Reviewing eTMF and collecting, tracking, and filing of essential documents required for the trial.
- Collaborated with Client for protocol team meetings and Develop and maintain good communications and working relationships with DM and project teams
- Develop and test databases and edit specifications
- Independently performed additional data cleaning tasks which includes logic checks, query management using listings and reports as needed
- Identified the trends in errors, made suggestive actions and develop strategies in co-ordination with the management to meet timelines and quality requirements.
- Reconciliation: SAE and LAB
- Reconcile project files, reports, listings and other documents generated in data management against a database for accuracy and completeness of data management processes.
Clinical Data Coordinator
Clinipace(Caidya)
, India
07.2017 - 04.2019
- Reviewing and resolving discrepancies identified by the system or through manual checks as per guidelines
- Issued Data Clarification Forms as and when required
- Track, review, update and close all DCF responses received
- Reviewing and performing quality checks (QC) on completed and ongoing clinical studies in electronic trial master files to identify any filing issues
- QC report preparation and collaboration with CRAs and CTAs to compile any missing documents and resolve QC findings
- NON-TMF filing- perform processing and filing of critical documents on an ongoing basis
- Coordinating with the CRAs to ensure that the sites update the data as per eCRF completion guidelines (CCG) and resolving issues regarding the clinical trial data.
- Organizing the paper documentation scanning process, ensuring that all scanned documents are appropriately classified, stored, and easily accessible, and ensuring that paper trial documents are scanned and indexed into the electronic TMF
Education
MSC - Health Service Management
Engineering Chester University
UK 10.2022 - 10.2023
Bachelor of Technology - Biotechnology
Calicut University
India 09.2012 - 04.2016
Higher Secondary Education - Science, Maths, English
Kerala board
IndiaGCSEs - Science
Kerala Board of Public Examination
IndiaSkills
- EDC Tools: Rave, Inform
- Clinical Trial Management Systems-CTMS
- Vendor Management: Labcorp, Suvoda, WCG, Judi, eCOA-Clario
- Veeva Vault eTMF,Wingspan,
- Amgen system and tools
- Clinical study report support(CSR)
- eTMF maintenance
- Cross functional team collaboration
- Audit & inspection readiness
- Team Leadership
- Regulatory compliance
- IRB / IEC submissions & approvals
- Data management
- recruitment & retention
- MS Office (Outlook, Word, Excel, power point)
Certification
Diploma in Clinical Research and Data Management from Clinovex Research Institute, India
Languages
English
Malayalam
Hindi
Tamil
Interests
Travelling and cultural exploration., Fitness activities, Active in social networking sites
Accomplishments
- Recognized several times by management and client for projects delivering quality.
- Participated in IRB submissions and regulatory document preparation.
- Consistently met study milestones and timelines.
- Supported successful enrollment of subjects while maintaining GCP compliance
- Assisted in data reconciliation and analysis support for CSR finalization.
Strenghts
- Able to adapt to new challenges and work environments with relative ease
- Quick learner
- Good communication skills
- Best under pressure
References
References available upon request.
Timeline
Associate Study Manager
ICON Plc
11.2023 - 01.2026
MSC - Health Service Management
Engineering Chester University
10.2022 - 10.2023
Clinical Data Specialist
IQVIA
05.2019 - 09.2022
Clinical Data Coordinator
Clinipace(Caidya)
07.2017 - 04.2019
Bachelor of Technology - Biotechnology
Calicut University
09.2012 - 04.2016
Higher Secondary Education - Science, Maths, English
Kerala board
GCSEs - Science
Kerala Board of Public Examination