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Kuwait Jobs Today: ICON Strategic Solutions Company announces new job opportunities. Are you looking for job opportunities in Kuwait? ICON Strategic Solutions Company announces the opening of recruitment for many jobs in various specializations in Kuwaiton today’s date. These opportunities are available to all nationalities. Learn about the available jobs and how to apply through the following advertisement.
Required jobs in ICON Strategic Solutions company and their details:
1- Medical Data Reviewer
What you will be doing:
- Responsible for ensuring the high quality medical review of phase I/II oncology clinical trial data, in compliance with GCP/ICH and regulatory requirements
- Provide high quality, timely and diligent clinical data review to ensure adequate data quality for the ongoing clinical development lifecycle
- Conducts medical review of the data as per Medical Data Review Plan (MDRP) on incremental listings and subject profiles in close collaboration with MD/CRS
- Reviews and approves all test outputs of listings/profiles in collaboration with the MD/CSR and Biometrics team
- Participates in/attends internal and external relevant meetings, as needed
- Provides input into the electronic Case Report Form (eCRF) and CRF Completion Guidelines (CGS), Medical Data Review Plan (MDRP) and related relevant documents
- Collaborate with relevant line functions to improve the quality of clinical data review/insights with an emphasis on subject safety and eligibility, efficacy endpoints, data integrity, trend identification, analysis and remediation, and identification of cases for medical review
- Assist in the development and monitoring of the data review strategy, ensuring that clinical data review findings are adequately implemented and resolved, leading to a front-loaded data cleaning and high quality study data
You Possess;
- Degree in life sciences/healthcare (or clinically relevant degree) is required. PhD, MBBS, BDS, MD strongly preferable
- 3 years (minimum) experience in Pharmaceutical industry/Clinical Research Organization, as a Medical Data Reviewer, Medical Monitor or similar roles
- Fundamental knowledge of Good Clinical Practice, clinical trial design including eCRF design, medical data review, statistics, regulatory processes, and clinical development process in Oncology
- Basic knowledge in planning, executing, and reporting global oncology clinical studies in a Pharmaceutical company or Contract Research Organization
- Proficient English (oral and written)
2- Manager, Drug Safety
The Manager Clinical Safety Operations is responsible and accountable for:
- Process for the medical safety follow-up queries for ICSRs from interventional clinical trials and non-interventional, post-authorization studies SAE reconciliation activities (interface to Global Data Management) for company sponsored phase I to IV clinical trials and non-interventional post -authorization studies
- Process for reconciliation of ICSRs exchanged with business/development partners and other sources (Global Medical Information)
- Maintenance of the study protocol library (with assignment of IM P/ non -IMP) and the company product dictionary in the global safety database (ARISg)
- Review of safety sections of trial related documents (e.g. Drug Safety Manual/ Safety Processing Plan, Trial Oversight Plan, SAE reconciliation plan)
- Contribute to trial specific resource and budget planning OM001-BP-T01/Version 5.0/Effective: 08-March-2021 (Ref. OM001-BP)
- Contribute to defining and implementing of clinical trial safety related activities in the alliance with relevant partners/service providers of sponsor and alignment of guidelines and processes related to clinical trial safety management with existing GDS processes
Education/Languages
- Health Care Professional with extensive work experience in pharmacovigilance area, clinical development, project management, IT Systems
- Fluent in written and spoken English
- University degree is an advantage or relevant professional experience equal to scientific studies
- Proven project and process management skills
Professional Experience
- Several years of professional experience (5-7 years) in Drug Safety/Clinical Trial Safety Management
- Sound understanding of regulations relevant to the safety of drugs in development and post authorization
- Excellent communication skills in an international environment
- Intercultural experience through successful collaboration in matrix teams
How to apply for jobs
To apply for the aforementioned jobs, you can follow these steps:
Source and additional details
- Job source: The official website of the company
- Posted Date: 3-7-2024 (Please check the date before applying).
- Required Nationalities: All nationalities.
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