• , US

Company:  Confidential

Job Title: Sr. Clinical Trial Manager

Job Number: 75876

Location: , US

Job Description

This individual will oversee clinical trials from protocol conception to the Clinical Study Report, ensuring completion of all study deliverables and resolving issues.

Responsibilities

* Independently lead and manage all aspects of clinical trials to ensure timely completion. * Contribute to study document development and regulatory submissions. * Select and oversee clinical trial vendors. * Build relationships with internal teams, vendors, investigators, and site staff. * Monitor trial progress and provide updates to teams. * Manage trial budgets and ensure data quality. * Lead study-related meetings and teleconferences. * Identify and mitigate risks to trial timelines and budgets. * Manage trials in accordance with SOPs and regulatory guidelines.

Required Skills

* Bachelor’s degree in health science or related field. * Minimum 5 years of clinical trial management experience, with 3+ years at a biotech/pharma sponsor. * Experience with Cell and Gene Therapy preferred; 3+ years Phase 1-3 experience in Oncology required. * Strong experience in facilitating clinical study team meetings with excellent communication skills. * Excellent organizational skills and ability to prioritize activities in a fast-paced environment. * Willingness to travel up to 20% (domestic and international).

Application Deadline: 2024-05-13

 

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