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Sr. Clinical Trial Manager

Austin, TX 78704

Posted: 12/20/2022 Employment Type: Contract To Hire Job Category: Clinical Development and Operations Job Number: 531342 Is job remote?: No Country: United States

Job Description

Primary Roles and Responsibilities
Describe the essential and frequent duties and responsibilities of the role  •    Responsible for the coordination of clinical operations required to initiate, execute, and complete clinical trials to drive on-time delivery of clinical trial milestones.
•    Participates in the identification, evaluation, and selection of clinical trial sites.
•    Creates and maintains clinical trial documents
•    Responsible for tracking of ancillary and investigational supplies, specimens and/or imaging.
•    Supports Clinical Trial Master System (CTMS) and Trial Master File (TMF) completeness.
•    Supports audit and/or inspection activities.
•    Performs all duties and responsibilities in accordance with Code of Federal Regulations (CFR), International Council for Harmonization/Good Clinical Practice (ICH/GCP) Guidelines, SOPs, and other applicable guidelines.
•    Completes training assigned by Client and/or Executive as necessary, including general training requirements, SOPs, and system and process related training.
•    Manage CRO, vendors, consultants and company study team members in cross functional areas.
•    Provide leadership and support to Supports Medical Monitor(s), Clinical Trial Manager(s), and collaborates with internal team members, CROs, vendors and sites.
•    Performs all duties and responsibilities in accordance with Code of Federal Regulations (CFR), International Council for Harmonization/Good Clinical Practice (ICH/GCP) Guidelines, SOPs, and other applicable guidelines.
Skill Requirements
List certain skills required to qualify for the role such as technical and soft skills (communication, Microsoft suite skills, use of specific tools or software systems, decision-making, strategic, analytical, et.) •    Excellent leadership, communication, and organizational skills. Able to multi-task under limited direction and on own initiative.
•    Must be action oriented, possess strong critical thinking and problem-solving skills. Interest in expanding skill set and upward mobility is a must.
Qualifications Requirements
List requirements candidate need to qualify and be successful in this role (specific degree, license, years of experience, etc.) •    Bachelor of Arts or Science (BA/BS) or equivalent or any relevant and qualifying training.
•    10+ years’ experience in clinical trial management
•    Must have multiple phase trial experience, with an emphasis on Phase 3 trials 
•    ICH GCP Certification preferred
•    Must have experience with INDs
•    Must have experience with ARDS; COVID and Pulmonary clinical research experience preferred
•    Must have in-patient experience
•    Must have Global Clinical Trial Management experience
Target Salary: $170-$185k. Salary will be commensurate with experience
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