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location: Deerfield, Illinois
job type: Contract
salary: $63.19 - 74.34 per hour
work hours: 9 to 5
The primary responsibility is to manage both national and global clinical trials and their associated clinical teams including timelines and budget for clinical trial execution and ensuring clinical trials are conducted in accordance with Global Clinical Development procedures, ICH GCP Guidelines, the Declaration of Helsinki and national regulations.
- May represent Global Clinical Development on Project Development Core Teams for device programs, supporting studies through for regulatory approval. Reports directly to the Director of Global Clinical Operations.
- Able to work independently to manage all aspects of a clinical trial from site selection/vendor selection process to database lock and review of the final clinical study report.
- Activities including management of product inventory, forms development, enrollment, budget, and timeline projections.
- Manage the interfaces with Legal, Global Project Management, Data Management, Medical Writing, Clinical Supply, Clinical Compliance and Training, Pharmacovigilance, and Biostatistics.
- Effectively manage external team/vendors activities including CRO, central lab, IRB and other external contractors.
- Interact effectively with Sr. Management to provide updates and communicate issues.
- Review other study documents such as protocols, Investigators brochures, DMPs, CRFs, SAPs, and CSR.
- Clinical Plan - Partner with the Medical Monitor and Regulatory Affairs to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program.
- Clinical Trial Protocols - Prepare directly or facilitate preparation of protocols including study design, case report forms, study procedures. Develop and complete enrollment feasibility evaluations based on protocol synopsis. Draft informed consents based on study and regulatory requirements.
- Research Agreements and Study Budgets - negotiate study budgets with sites.
- Identify clinical investigators and assess suitability of study sites. Recognize and maintain strong business relationships with key opinion leaders.
- Plan and conduct investigators meetings.
- Order clinical supplies and ensure logistics plans are in place prior to study start.
- Train study staff on product usage, data collection and specific procedures.
- Comprehensive knowledge and understanding of European/FDA regulations and ICH Guidelines for Good Clinical Practices required.
- Ability to maintain effectiveness under changing circumstances and priorities. Tact and diplomacy is a strength.
- Excellent verbal and written communication and organizational skills required.
- Knowledge of computer software and meticulous attention to detail expected for this position.
- Confident decision-making and ability to work effectively as a team leader, team member, or individually.
- Proficiency in data collection design, scientific evaluation and clinical planning.
- Demonstrated ability to represent Clinical Operations in global project teams, execute clinical strategies and manage complex programs in a fast paced milestone focused environment.
- Has a track record of delivering on commitments. Capable of handling (assimilating) in-depth technical information from a variety of disciplines in order to be scientifically credible within the global team.
- Bachelor of Science in Scientific or Engineering discipline
- 5+ years medical device (class II & III) clinical development experience
- 3+ years Project Management experience,
- PMP certification, nice to have
- Software: MS Word, Excel (pivot tables, v-lookups), Outlook, PowerPoint, SharePoint, MS Project
- Position allows for flexibility in work week with ability to work from home up to 2 days/week at supervisors discretion.
- Has working knowledge and familiarity with US Federal Food and Drug Administration, ICH/GCP, and European Regulatory Authority requirements as applicable to a study.
- Excellent verbal and written communication skills required. Interpersonal and organizational skills a must.
- Ability to multitask with a strong attention to detail.
- Possess working knowledge of research objectives, protocol design and data collection standards.
- Must demonstrate leadership skills in order to direct clinical team in study preparation and execution.
- Comprehensive understanding of the drug/device development process.
- Solid technical basis in pharmaceutical development and delivery systems technologies.
- Proven ability in planning and conducting clinical trials.
skills: Project Management, CRF, Clinical research, MS-WORD, MS-EXCEL, MS-Powerpoint, MS-Project, GCP (Good Clinical Practice), Clinical Study Design, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.