Senior Clinical Study Manager

POSITION SUMMARY

This position is for overseeing clinical activities related to one or more clinical studies and performing/managing the daily in-house operations associated with the studies. The Clinical Study Manager must be able to work independently on multiple complex clinical studies using critical thinking skills. This position may be part of a small, cross functional team or may have direct reports.

MAIN DUTIES/RESPONSIBILITIES

• Responsible for managing clinical studies in accordance with internal standard operating procedures and applicable regulations and guidelines
• Collaborate with internal and external clinical team members, consultants and/or CROs to draft clinical study protocols and other clinical study documentation
• Oversee clinical site selection and activation
• Manage study safety by tracking and reporting adverse events as required by regulatory bodies, reviewing adverse event trends, and overseeing safety committees including Clinical Events Committees and Data Safety Monitoring Boards
• Oversee monitoring activities related to assigned clinical studies including review and approval of monitoring plan and monitoring reports, managing monitoring schedule and ensuring corrective action related to monitoring findings
• Develop training plans for study training and review/approve training documentation
• Prepare study-related reports including annual, interim and final study reports
• Organize and lead study-related conference calls and Investigator meetings as needed through the study
• Oversee investigational device allocation, distribution and reconciliation
• Collaborate with data management team and/or CRO to ensure appropriate data capture, query management and to identify data analysis needs
• Use critical thinking skills to review and analyze scientific journal articles
• Assist with generation and/or review of study-related abstracts, posters, presentations, manuscripts as needed

QUALITY SYSTEM RESPONSIBILITIES

• Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
• Complete training requirements and competency confirmations as required for this position within the required timeline.
• Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
• Ensure all direct reports maintain training records that comply with applicable quality system requirements. (if applicable)

QUALIFICATIONS

Educational Requirements:

• Required: Bachelor's Degree required
• Preferred: Science Degree preferred (Biology, Chemistry, etc.)

Required Experience:

• Previous clinical research experience (minimum 5 years) required
• Previous clinical study management experience preferred
• International clinical experience preferred
• Previous collaboration with physician investigators
• Strong knowledge of clinical research study design and study monitoring functions
• Understanding of GCP and 21 CFR 812
• Experience working with Institutional Review Boards and/or Ethics Committees
• Strong technical writing skills

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