Clinical Trial Manager Jobs

*Must be LOCAL to Chicago*

THE OPPORTUNITY:

We are looking for a Clinical Trial Manager/Clinical Affairs Manager to join our team. You will work with hardware, application, and other cross-functional teams to react quickly and produce quality solutions to difficult technical challenges. Our fast-paced environment offers ample opportunities for growth in several areas: improved technology skills, effective leadership, dedicated mentorship, creative design, strong communication skills, teamwork, and more.

WHAT YOU WILL BE WORKING ON:

• Ensure adequacy of data acquisition and management, and timely completion of studies and associated projects.
• Oversee the operational aspects for the development and delivery of standard study protocols, informed consents, vendor selection/management and site selection and recruitment strategies.
• Provide strategic input to clinical trial design and protocol development.
• Support regulatory audits and inspections.
• Identify and communicate project objectives, propose innovative solutions to potential obstacles in study conduct, study sites, or with CROs.
• Foster a culture and environment of innovative clinical research excellence.
• Manage the operation of clinical program(s) to ensure compliance with regulatory requirements.
• Participate in protocol deviation listing reviews and meetings.
• Ensure adequate study resources to successfully complete clinical project and programs on-time and on-budget.
• Evaluate CROs for their ability to execute clinical trial work, compare budgets and timelines and make recommendations to senior management.
• Lead/represent Clinical Affairs team, processes, programs across our company and external venues in partnership with senior management.
• Develop and execute on clinical strategy to generate data for regulatory activities and other purposes.
• Drive the development of SOPs and other procedural documents.
• Participate in data cleaning, listing, and report output reviews.
• Develop, review, and approve study-related plans, specifications, instructions for use, charters, newsletters, and materials.
• Interact with other functional areas and key stakeholders, including Data Management, Regulatory, R&D and clinical vendors as needed, to support clinical activities.
• Provide guidance on all clinical operation logistics associated with execution of clinical studies (including clinical supplies, sample shipments etc.)
• Maintain up-to-date knowledge of published literature in relevant therapeutic areas including the key clinical operations issues.
• Develop and provide input on CRF development and completion guidelines.

ABOUT YOU:

• Bachelor's degree in a life science field required.
• Prior experience in management and monitoring of CRO and investigative sites.
• Experience managing projects and working with clinical professionals and cross-functional product development teams.
• Experience utilizing clinical systems.
• Knowledge of ICH, GCP, IRB/IEC, and local regulatory authority.
• Knowledge of clinical practices in industry.
• 6+ years experience managing clinical studies/activities.
• Excellent written and verbal communication skills and the ability to work with various levels of the Company.
• Highly organized and detail-oriented, with solid analytical skills.