Experience

WorldCare Clinical

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Cinical operations associate

  • Dec 2021 - Present

  As a Lead Clinical Operations associate my roles and responsibilities include Site Management, Query Management, Data reconciliation, case assignment, Trial master File management and image processing in various clinical studies of phase I/II , Phase II, and phase III. Executed clinical services and met planned deliverables in line with defined roles and responsibilities agreed with colleagues/customers. Supported set-up and maintenance of Trial Master File (TMF): Ensuring that all key documents are present and filed as appropriate in TMF. Followed up with Clinical Trial Team at agreed frequency for TMF maintenance.Tracked clinical service progress, ensured Clinical trial management systems (CTMS) , TMF and other systems as applicable are up to date, reported to colleague/customer as per scope of work. Addressed questions; escalated issues or critical findings to project lead (Sr./CPM). Supported (Sr.) CPM in set up and coordination of External Service Providers, ensuring all information, documentation, and material in place for study start during study conduct and close-out. Followed-up with External Service Providers on day-to-day operations.Ensured to report all the data to the Clinical Trial Team and available to colleague/customer. Worked on applications like Medidata rave imaging, ecaselink, and WorldPro for data management and image management. Validated and maintained imaging database including images and patient data as per study specific guidelines and SOP’s and reviewed results for assigned projects. Issued and Reviewed Queries for missing, Inconsistent, Illegible, or erroneous data and followed site personnel until resolution of queries. Communicated with the team members and collaborated with other stake holders on project requirements and deliverables and project challenges. Assisted in tracking and management of case report forms (CRF’S), queries and Clinical data flow. Show less

• Clinical Operations Coordinator

  • Jul 2021 - Dec 2021



CALYX

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Imaging research associate

  • Jan 2021 - Jul 2021

  Worked as an Imaging Research Associate and gained comprehensive experience with regards to image processing and query management in phase I to Phase III clinical studies of various indications. Performed quality assurance checks on medical imaging data to ensure protocol specific requirements are met. Performed established Image processing techniques across multiple modalities such as CT, MRI, Bone scan, PET and DXA. Performed project specific tasks in compliance with Good Clinical Practices (GCP), regulatory requirements (21CFR Part 11), applicable departmental and companywide SOPs, and project specific protocols. Performed Data reconciliation task and worked on the discrepant data raised. Undergone Various project specific trainings and worked on phase I,II and III clinical studies in various indications including Oncology, Osteoporosis and Osteopenia for various clients including Novartis, Pfizer, AstraZeneca, BI, Genmab, C-Stone, Clementina, Acreta Pharma, Takeda etc. Validated and maintained imaging database including images and tracked patient data and reviewed results for assigned projects. Show less



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Imaging Research Associate

  • Mar 2018 - Jan 2021

  Working on quality check of images of different modalities including CT,MRI,X-RAY,BONE SCAN,PET,DXA of oncology studies with various indications, and tracks the data in the application in collaboration with subject details and image information. Working on quality check of images of different modalities including CT,MRI,X-RAY,BONE SCAN,PET,DXA of oncology studies with various indications, and tracks the data in the application in collaboration with subject details and image information.



Vimta Labs Ltd

• India
• Research Services
• 700 & Above Employee

• Trainee scientist

  • Jan 2017 - Feb 2018

  Worked on Analysis of drugs using ionexchange chromatography instrument. Worked on Analysis of drugs using ionexchange chromatography instrument.