About ICON plc
ICON plc is a global provider of drug development and commercialization services to the pharmaceutical, biotechnology, and medical device industries. With headquarters in Dublin, Ireland, ICON operates in over 40 countries and offers a comprehensive range of services spanning clinical trial management, laboratory services, consulting, and commercialization support.
The company’s expertise covers various therapeutic areas, including oncology, central nervous system disorders, cardiovascular diseases, and infectious diseases, among others. ICON’s services encompass all stages of the drug development process, from preclinical research through to post-marketing studies.
Utilizing advanced technologies and data analytics, ICON aims to streamline the drug development process, accelerate timelines, and enhance the efficiency and success rates of clinical trials. Additionally, the company provides regulatory and strategic guidance to clients, helping them navigate complex regulatory landscapes and bring their products to market effectively.
ICON plc’s commitment to innovation, quality, and client satisfaction has established it as a leading player in the global contract research organization (CRO) industry, supporting the advancement of medical science and the development of life-saving therapies.
Post: Medical Data Reviewer
Job Description:
Serve as a Clinical Data Reviewer:
- Identify errors in data by performing comprehensive data reviews, requiring further clarification with study sites.
- Conduct ongoing reviews of clinical/medical aspects of patient data and documents, escalating issues as necessary.
- Examples include patient eligibility, diagnosis, medical history, study drug administration, adverse events, safety labs, efficacy assessments, etc.
- Issue clinical data queries and ensure timely follow-up on responses from study sites.
Communication and Training:
- Communicate data training needs for CRAs and sites.
- Conduct in-stream data trend analysis to support data quality and integrity.
- Provide clinical data project management and expertise in data review and cleaning.
Quality Assurance and Compliance:
- Ensure data quality for audit readiness.
- Assist in reviewing data capture requirements in line with protocol and reporting needs.
- Monitor site data entry performance and identify root causes of data issues.
Continuous Improvement and Participation:
- Continuously assess opportunities to enhance task efficiency and data quality.
- Participate in various clinical data review meetings and data dissemination activities.
- Collaborate closely with Client Clinical Scientists, Medical Directors, Data Management, and Clinical Operations.
Candidate Profile:
- Educational background in MD, PharmD, PhD, Nursing degree, or MSc.
- ≥ 5 years of pharmaceutical clinical/medical data review experience, preferably 8+ years.
- Experience in Solid Tumor Oncology.
- Excellent verbal and written communication skills in English.
- Detail-oriented with strong organizational and tracking skills.
- Experience in coding review and query writing training.
- Strong clinical database navigation and MS Excel skills.
- Proven ability to work independently and in a team setting.
- Knowledge of Good Clinical Practice and clinical trial design.
Additional Information:
- Experience: ≥ 5 years
- Qualification: MD, PharmD, PhD, Nursing degree, MSc
- Location: India
- Industry Type: Pharma/Healthcare/Clinical Research
- Functional Area: Medical & Scientific Affairs
- End Date: 25th May 2024
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