- To conduct high-quality research according to the International Conference on Harmonization (ICH), Guidelines for Good Clinical Practice (GCP), National Institute of Health (NIH), Food and Drug Administration (FDA) and be in compliance with local, state and federal regulations
- To promote and strengthen professional development of staff
- To become recognized as an outstanding CRO for industry-sponsored clinical research
- To advocate the value of research as a means of good quality of care in wound healing, podiatry and orthopedics
- To provide personnel and infrastructure support for clinical research within the organization
- Education: Must have Bachelor's degree preferably in business management, biology, health sciences,
healthcare or any related field or comparable industry experience. Preferred to have advanced degree. - Experience: Minimum of 4 years of clinical research experience, preferred to have 1 years of management
experience. Must have exceptional leadership, technical and communication skills at both the site and Sponsor
level. Ability to multitask and maintain excellent organizational skills. - Oversee all aspects of clinical research trials ensuring protocols, contracts, GCP and applicable
regulations are followed. - Direct and coordinate all clinical trial activities by employing effective organizational and communication
skills - Manage day-to-day operations of the study from start-up to database lockout according to
ICH/GCP, SOPs, and all other applicable laws, rules and regulations - Serve as primary Sponsor and Vendor contact for operational project-specific issues and study
deliverables - Provide oversight for project team and third-party vendors, ensuring all cross-functional deliverables are
met - Maintain in depth knowledge of protocol, therapeutic area and indication
- Review and provide input for studies including, but not limited to, protocol writing, inform consent
form, edit check specifications, contracts and budgets, regulatory submission strategies, and final study
report - Develop study management tools, including operational study plans and project timelines
- Act as initial resource for study CRA's and sites with any protocol related questions
- Provide oversight to ensure timely reporting and processing of AE's and SAE's to the Sponsor
- Facilitate CTA negotiation and approve site payments and work closely with the Controller
- Provide direct supervision of PERI Administrative Coordinators
- Appropriately communicate site feedback and correspondence as applicable to the Senior Director of
Clinical Trial Operations or the PERI Executive Committee and the Sponsor. - Assist with monitoring data for completeness and accuracy (via centralized or remote monitoring), onsite monitoring, and completing monitoring reports and letters for post market clinical trials.
- Provide trial updates in a timely manner to the Sponsor and other designated individuals following
appropriate templates, including managing team teleconference, as required. - Review CRA monitoring reports for completion and accuracy.
- Starting salary rate is $80,000 to $105,000. Pay rate will be determined based on experience.
- PERI Standard Operating Procedures
- PERI Employee Handbook
- PERI Travel and Entertainment Policy
-
Clinical Trial Manager
1 week ago
Professional Education and Research Institute Cincinnati, United StatesMission Statement · PERI is an organization dedicated to promoting good quality of care in wound healing, podiatry and orthopedics through the pursuit of quality clinical research and trial management. · Goals for PERI's research mission are the following:To conduct high-quality ...
-
Clinical Trial Manager
4 weeks ago
Professional Education and Research Institute Cincinnati, United StatesMission StatementPERI is an organization dedicated to promoting good quality of care in wound healing, podiatry and orthopedics through the pursuit of quality clinical research and trial management.Goals for PERI's research mission are the following:To conduct high-quality resear ...
-
Clinical Trials Manager
3 weeks ago
INTELLECTT INC Cincinnati, United StatesPosition · : Clinical Trials Manager · Location · : Cincinnati OH 45227 · Duration · : Full-Time · Work Type · : Onsite/Hybrid · Job Description · Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/ ...
-
Clinical Trial Manager
1 week ago
Professional Education and Research Institute Cincinnati, United StatesMission StatementPERI is an organization dedicated to promoting good quality of care in wound healing, podiatry and orthopedics through the pursuit of quality clinical research and trial management.Goals for PERI's research mission are the following:To conduct high-quality resear ...
-
Clinical Trials Manager
3 weeks ago
INTELLECTT INC Cincinnati, United StatesPosition : Clinical Trials Manager · Location : Cincinnati OH 45227 · 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 Managem ...
-
Clinical Trial Manager
4 weeks ago
Medpace Cincinnati, United StatesJob Summary: · Medpace will be hosting a remote informational session to highlight our Clinical Trial Manager role. The virtual event will overview Medpace, our robust CTM career path, and be an excellent opportunity to network with our CTM hiring team. · Date: Tuesday, April 3 ...
-
Clinical Trial Manager
2 weeks ago
Medpace Cincinnati, United States Full timeMedpace is the leading CRO for Biotech companies and is continuing to add Clinical Trial Managers with established Clinical Research Nursing backgrounds to join our Clinical Trial Management Group in our Cincinnati, Dallas, and Denver offices. Our therapeutic areas of focus inclu ...
-
Clinical Trial Manager
2 weeks ago
Medpace Cincinnati, United States Full timeMedpace 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, Neurosc ...
-
Clinical Trial Project Manager
2 weeks ago
Medpace Cincinnati, United StatesJob Summary: · Medpace is the leading CRO for Biotech companies and is continuing to add established Clinical Trial Managers and Project Managers with a focus on Infectious Diseases to join our Clinical Trial Management Group. We have just expanded our campus in Cincinnati and h ...
-
Clinical Trial Project Manager
1 day ago
Medpace Cincinnati, United StatesJob Summary: · Medpace is seeking a Clinical Trial Manager to act as project lead for full service global clinical trials for Medical Devices. We are looking for experience within Medical Devices for Metabolic, Cardiovascular, Diabetes, and more. The position interacts with spon ...
-
Director, Clinical Trial Management
3 weeks ago
Medpace Cincinnati, United StatesJob Summary: · Medpace is the leading CRO for Biotech companies and is continuing to add senior-level Directors and established Project Managers to join our Clinical Trial Management Group in Cincinnati, OH, or remotely with relevant experience. Our therapeutic areas of focus in ...
-
Associate Clinical Trial Manager
2 weeks ago
Medpace Cincinnati, United States Full timeMedpace is a leading CRO for Biotech companies and we are currently seeking candidates with PhDs and/or Post-Doctoral Research experience for a full-time, office-based Associate Clinical Trial Manager (aCTM) to join our Clinical Trial Management team. The aCTM will be a part of t ...
-
Clinical Trial Manager- Biosciences
3 weeks ago
The Procter & Gamble Company Cincinnati, United StatesEntry level for employees who develop proficiency in Biosciences. Procedural work and expertise in Application work by combining hands-on experimentation with scientific principles and knowledge from science/engineering education to drive foundationa Clinical, Manager, Science, B ...
-
Director, Clinical Trial Management
2 weeks ago
Medpace Cincinnati, United States Full timeMedpace is the leading CRO for Biotech companies and is continuing to add senior-level Directors and established Project Managers to join our Clinical Trial Management Group in Cincinnati, OH, or remotely with relevant experience. Therapeutic area of focus is Oncology, Hematology ...
-
Clinical Trial Project Manager
1 week ago
Medpace Cincinnati, United States Full timeMedpace is the leading CRO for Biotech companies and is continuing to add established Clinical Trial Managers and Project Managers with a focus on Oncology/Hematology to join our Clinical Trial Management Group. We have just expanded our campus in Cincinnati and have offices in D ...
-
Clinical Trial Project Manager
1 week ago
Medpace Cincinnati, United States Full timeMedpace is the leading CRO for Biotech companies and is continuing to add established Clinical Trial Managers and Project Managers with a focus on Ophthalmology to join our Clinical Trial Management Group. We have just expanded our campus in Cincinnati and have offices in Dallas ...
-
Clinical Trial Project Manager
1 week ago
Medpace Cincinnati, United States Full timeMedpace is the leading CRO for Biotech companies and is continuing to add established Clinical Trial Managers and Project Managers with a focus on Infectious Diseases to join our Clinical Trial Management Group. We have just expanded our campus in Cincinnati and have offices in D ...
-
Clinical Trial Project Manager
2 weeks ago
Medpace Cincinnati, United States Full timeMedpace is the leading CRO for Biotech companies and is continuing to add established Clinical Trial Managers and Project Managers with a focus on Cardiovascular, Renal, and Metabolic therapeutic areas to join our Clinical Trial Management Group. We have just expanded our campus ...
-
Director, Clinical Trial Management
1 week ago
Medpace Cincinnati, United States Full timeMedpace is the leading CRO for Biotech companies and is continuing to add Directors and established Project Managers to join our Clinical Trial Management Group in Cincinnati, OH, or remotely with relevant experience. Therapeutic area of focus is Cardiovascular/Metabolic and more ...
-
Clinical Trial Project Manager
1 week ago
Medpace Cincinnati, United States Full timeMedpace is the leading CRO for Biotech companies and is continuing to add established Project Managers with a focus on Neuroscience to join our Clinical Trial Management Group. We have just expanded our campus in Cincinnati and have offices in Dallas and Denver, and provide remot ...
Clinical Trial Manager - Cincinnati, United States - Professional Education and Research Institute
Description
Mission StatementPERI is an organization dedicated to promoting good quality of care in wound healing, podiatry and orthopedics through the pursuit of quality clinical research and trial management.
Goals for PERI's research mission are the following:
Polices to be observed by all PERI employees include, but not limited to, the following: