Scientific Affairs Manager

• Responsible for overall coordination and management of Collaborative Studies from concept/proposal submission support, review, collaboration steps, start-up to study close-out, including agreement execution, study material tracking, gathering and communicating periodic study updates, timely execution of study, tracking publication timelines and review, invoice submissions and other activities.
• Tracks and supports study start up activities - essential documents, planning shipments, discussing milestones, finalizing agreements etc
• Performs an initial review of the concept/proposal along with the Investigators’ curriculum vitae.
• Documents all study communication with Investigator and site personnel.
• Works cross-functionally and communicates to internal teams (Regulatory, PMO, R&D) proactively and in a timely manner.
• Acts as an additional resource for technical questions, inquiries and troubleshooting.
• Manages standard response documents and custom responses. Maintains repository for global medical information
• Provides i-STAT system training (when necessary) and related documentation to ISS study site staff, following the approved study protocol and agreement.
• Supports publication plan review and tracking of manuscripts and other related publications concerning ISS/collaborative studies.
• Updates SOPs and documents related to Collaborative Studies. 
• Performs continual independent review of medical/scientific literature and competitor's diagnostic devices. Supports updates to the publications repository.
• Critically evaluates medical/scientific literature and determines appropriate usage.
• May provide support for Scientific Advisory boards
• Identifies and adapts to shifting priorities and competing demands.
• Responsible for managing the study budgets.
• Understands and complies with applicable EHS policies, procedures and guidelines.
• Responsible for implementing and maintaining the effectiveness of the Quality System.  

• Minimum of at least 5 years clinical research/medical affairs/project management experience.
• Knowledge and experience in working with clinical trials and managing research studies
• Knowledge and understanding of statistical techniques, performing data analysis, tracking clinical studies and publications.
• Understanding of the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage, and the scientific, statistical, regulatory and compliance requirements of clinical research.
• Bachelor’s Degree required.
• Willing and able to travel up to 25% of the time to meet investigators and clinical trial staff.

• Experience with managing publications
• 8 or more years of experience is preferred in similar area.
• Advanced degree (master's or PhD or MD) is preferred.
• Experience running clinical trials in international geographies (preferred).
• Influence and lead both with and without direct authority.
• Ability to clearly, concisely and accurately communicate (written and oral)
• Ability to confidently speak in public, lead meetings and group discussions
• Form and develop long-term strategic and professional relationships; display socially and professionally appropriate behavior.
• Ability to work independently and in groups
• Demonstrated leadership skills, initiative, critical-thinking and problem-solving skills
• Strong organization and time management skills

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