Job Title: Clinical Project Manager (Manager, Clinical Operations):
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 Client 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 drug and 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, Investigator's 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.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
List knowledge, skills, and/or abilities required.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• 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.
• Include the education and experience that is necessary to perform the job satisfactorily.
• BS in scientific discipline + 5 years pharmaceutical and/or device clinical development experience with 3+ years project management experience.
• 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 supervisor's discretion.
Interview Platform: Phone followed by onsite interview.
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.
At Sunrise Systems, we provide cost effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.
Our collective business experience spans over two and a half decades and ranges from: