Clinical/Medical Scientist (Medical Monitoring) - Oncology - Phase I

Job Responsibilities

• Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan).
• Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans.
• Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews.
• Pro-actively identifies and resolves medical data review issues as they arise.
• Authors medical data queries and reviews query responses, approves query closure in association with Medical Director.
• May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed.
• PARTNERS WITH MEDICAL DIRECTORS FOR MEDICAL DATA REVIEW MEETINGS AND SAFETY REVIEW MEETINGS INCLUDING SLIDE PREPARATION AS NEEDED.
• MANAGES PROJECT SCOPE OF WORK, OBJECTIVES, AND QUALITY OF DELIVERABLES TO ENSURE THE PROJECT SPECIFIC MILIETS AND TIMELINES ARE MET.
• SERVES AS PRIMARY INTERFACE BETWEEN INTERNAL TEAM, CUSTOMERS, AND VENDORS IN THE AREAS OF MEDICAL DATA REVIEW AND ELIGIBILITY REVIEW.
• COLLABORATES WITH STUDY TEAM MEMBERS INCLUDING CLINICAL OPERATIONS, DATA MANAGEMENT, DRUG SAFETY AND PHARMACOVIGILANCE, AND PROJECT MANAGEMENT (SET-UP AND/OR LEAD MEETINGS AS APPROPRIATE) TO IDENTIFY RISKS RELATED TO DATA INTEGRITY AND SUBJECT SAFETY.
• Escalates ongoing and newly developed study concerns such as at-risk project deliverables and out-of-scope tasks to the project leads in a timely manner.
• Attends and presents at Trusted Process meetings and may participate in internal and external audits.
• ACQUIRES BASIC UNDERSTANDING AND KNOWLEDGE OF ONGOING PROTOCOL DESIGNS AND DISEASE RELATED TERMINOLOGY AND PATHOLOGY.

Requirements

Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans.

Adheres to customer policies and standard operating procedures, as required in project plans.

Qualifications

Basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology.

Skills

Scientific knowledge, scientific knowledge of protocol-specific requirements, scientific knowledge of data quality, scientific knowledge of data integrity, scientific knowledge of data visualization, scientific knowledge of data analysis, scientific knowledge of data patterns/trends, scientific knowledge of data risk identification, scientific knowledge of data review, scientific knowledge of data query authoring, scientific knowledge of data query response review, scientific knowledge of data query response approval, scientific knowledge of data query closure, scientific knowledge of data review documentation, scientific knowledge of data review issue identification, scientific knowledge of data review issue resolution, scientific knowledge of data review meeting attendance, scientific knowledge of data review meeting presentation, scientific knowledge of data review meeting slide preparation, scientific knowledge of data review meeting escalation, scientific knowledge of data review 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