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Description
Under the guidance of the Sr Director, Clinical Safety Data Review (SDR) Oncology Business Group, performs quality review of Safety Data by reconciling the information from Safety report with Clinical Database. Ensures medically relevant information is captured in the Clinical database data entry fields. Ensures the Clinical Summaries for the subjects meeting the criteria of serious adverse events, adverse events that led to study discontinuation and clinically significant events were written with coherence, flows adequately, and captures accurate medical information.
Responsibilities include but not limited to performing clinical assessment and quality check review of clinical summaries. Ensuring queries are posted and actioned within the expected timelines.
Discusses difficult cases and data discrepancies with Sr Manager or above. Collaborates with Study Team/Medical Writing team for timelines of submission and with Data Operations to ensure the tracking of Subjects meeting the criteria for clinical summary is accurate and adequate for a particular milestone.
Confirms that the Clinical Summaries were written with quality, accuracy and relevant medical information. Observes the Leading Pharmaceutical / Biotech Company writing guidelines and study specific writing guidelines. Collaborate with other study teams across therapeutic areas on safety related matter especially SAE reconciliation.
Generates Clinical summaries as requested by the IPTL or President or the agency
Consults with Study Directors to resolve safety data review issues/queries. Interface with Data Operations for System issues.
Position is essential in ensuring quality of safety information in the clinical databases for submission, which is an FDA requirement, but also essential for bringing a compound to market
May provide scientific description of events necessary for submission.

Key Responsibilities:
1. Performs clinical assessment and quality check review of safety data within Clinical database.
2. Confirms Clinical Summaries with quality, accuracy and relevant medical information. Observe the Leading Pharmaceutical / Biotech Company writing guidelines and study specific writing guidelines
3. Ensuring queries are posted and actioned within the expected timelines
4. Participate in the development and implementation of department standards and documents as needed

Qualifications

Advanced health care degree, master degree in medical science, Nursing, Pharmacy or relevant biological science or healthcare field plus a minimum of 4 years of experience in job offered.
Requires at least 3 years of medical/clinical data review
Familiar with scientific writing guidelines for submission documents
Use of I/J Review, Inform, and other tools collecting Clinical data and Word or Excel is a plus
Requires at least 2 years of experience supporting Oncology studies and reviewing data in Case Report Forms; managing CRO global team and supporting Oncology studies).


Associated topics: ascp, lab, medical, medical lab science, scientist, surgical technologist, technician ii, technician lab, technician laboratory, toxicology

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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