Don't worry, we can still help! Below, please find related information to help you with your job search.
- Clinical Project Manager
- Senior Clinical IS Project Manager
- Clinical Operations Project Manager
- Clinical Research Project Manager
- Associate Clinical Project Manager
- Assistant Clinical Project Manager
- Clinical Trial Project Manager
- Clinical Study Project Manager
- Clinical Supply Project Manager
- Clinical Operation Project Manager
Clinical Project Manager Jobs
Company | VIVA USA Inc. |
Address | Deerfield, IL, United States |
Employment type | CONTRACTOR |
Salary | |
Expires | 2023-07-19 |
Posted at | 10 months ago |
Description:
Clinical Project Manager
Summary:
Responsible for managing the organization and conduct of clinical studies in compliance with Clinical Operations policies and procedures, Regulatory (Health) Authority requirements and guidelines, and International Conference on Harmonization (ICH) Guidelines in support of global business objectives. Reports directly to the Director of Clinical Operations. The Clinical Project Manager plans for and executes the required global or domestic clinical development plan of drugs and devices to generate data to support the launch and expansion of critical treatments for patients. This data serves to globally support regulatory submissions, post-marketing complaint handling and promotional claims for marketing strategies. The Clinical Project Manager also consults with regulatory, engineering, marketing, sales and research groups in problem solving efforts.
Essential Duties and Responsibilities:
• Partner with relevant client functions to develop clinical study plan for each project including timelines and budgets for the clinical program.
• Prepare directly or facilitate preparation of study documentation including protocols, case report forms, informed consent, enrolment feasibility evaluations and all relevant internal plans required for study conduct.
• CRO management (when applicable): Lead the day-to-day oversight of the CRO personnel plus the project budget, deliverables and timeline/milestones.
• Site activities (either directly or managing others): Identify and assess study sites, conduct investigator meetings and site training, prepare and execute research agreements and negotiate study budgets.
• Study monitoring (either directly or managing others): Formulate clinical monitoring plan, perform study initiation visits, manage clinical study monitoring resources, oversee standard interim monitoring visits and closeout activities
• Perform study closeout procedures, directly or through other resources, including accurate completion of critical documents, disposition of study product and preparation of study sites for regulatory authority audits.
• Develop and maintain tracking systems as needed for study management, e.g. screening, enrolment, study completion, (serious) adverse events, budgets and forecasts, milestones.
Qualifications, Education and/or Experience:
• Minimum: BA/BS in scientific field with minimum of 5 years clinical operations experience (pharmaceutical, biotechnology or medical device industry) preferably with 1-2 years of direct CPM experience.
• Has familiarity with US Federal Food and Drug Administration, ICH/GCP and European Regulatory Authority requirements as applicable to a study (or the countries a study is conducted in)
• Has understanding of the development process from Phase 1 through Phase 4 for drug and/or device trials
• Possesses working knowledge of research objectives, protocol design, and data collection standards
• Experience with clinical operations systems including EDC, CTMS, and eTMF
• Experience in project management practices
Note :
Shift
USA-1
-
Systems Analyst - Excel, Xml, Sql, Scripting
By CyberCoders At Salt Lake City, UT, United States 8 months ago
-
(Senior) Finance & Shared Services Manager
By Catholics For Choice At Washington, DC, United States 8 months ago
-
Paralegal - Probate Administration
By CyberCoders At Miami, FL, United States 8 months ago
-
Account Executive - Automotive Software
By ECW Search At United States 8 months ago
-
Construction Project Coordinator Jobs
By CyberCoders At River Falls, WI, United States 8 months ago