What are the responsibilities and job description for the Clinical Trials Manager position at TekWissen ®?
Overview
The Client is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40 countries.
Position : Clinical Trials Manager
Location : Cincinnati OH 45227/Dallas, TX
Duration : Full-Time
Job Type : Full-Time
Work Type : Onsite/Hybrid
Job Summary
The Client is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40 countries.
Position : Clinical Trials Manager
Location : Cincinnati OH 45227/Dallas, TX
Duration : Full-Time
Job Type : Full-Time
Work Type : Onsite/Hybrid
Job Summary
- The Client is the leading CRO for Biotech companies and is continuing to add established Project Managers to join our Clinical Trial Management Group in Cincinnati, OH. Our therapeutic areas of focus include Oncology/Hematology, Cardiovascular/Metabolic, Infectious Disease, Neuroscience, and more. We have just expanded our campus in Cincinnati and have offices in Dallas and Denver and provide remote flexibility with relevant experience. We offer a very competitive salary/bonus program, plus equity grants which have become very lucrative for our associates.
- Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations
- Serve as primary Sponsor contact for operational project-specific issues and study deliverables
- Maintain in depth knowledge of protocol, therapeutic area, and indication
- Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided
- Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable
- Develop operational project plans
- Manage risk assessment and execution
- Responsible for management of study vendor
- Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables
- Bachelor’s degree in a health-related field; Advanced degree in a health-related field preferred
- Experience in Phases 1-4; Phases 2-3 preferred
- 5 years as a project/clinical trial manager within a CRO; required for home-based
- Management of overall project timeline
- Strong leadership skills
Clinical Support Associate
Velocity Clinical Research, Inc. -
Mount Auburn, OH
