Scientific Affairs Manager

Abbott • Princeton, NJ

2d • $113,300 - $226,700 • Onsite

About The Position

Abbott Point of Care is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective. Our i-STAT System is an advanced, portable diagnostic tool that provides real-time, lab-quality results within minutes to accelerate patient-care decision-making. The i-STAT System has the industry’s most comprehensive menu of tests in a single, with-patient platform, including tests for blood gases, electrolytes, chemistries, coagulation, hematology, glucose, and cardiac markers. By delivering lab-quality results in minutes, our i-STAT System fosters a collaborative, patient-centered environment while driving improved operational performance. The Scientific Affairs Team has an opportunity for a Manager, Global Scientific Affairs. The Manager, Global Scientific Affairs will be responsible for overall coordination of investigator sponsored studies (ISS) and collaborative studies (CRS) from initiation of study discussions and scientific engagement, oversight of the concept/proposal submission, review & collaboration, start-up to study close-out, including agreement execution, study material shipment, gathering and communicating periodic study updates and, timely execution of study. This position will involve pre-review of all study concepts/proposals, preparing review and presentation materials for the scientific review committee (SRC) and managing collaborative study protocol versions with APOC and Principal Investigator(s). The Scientific Affairs Manager will also liaise with cross-functional team members including clinical, regulatory, quality, legal, supply chain and will be responsible for managing individual study budgets/milestone payments. The person hired will provide product training, study design, protocol and/or workflow development. The Scientific Affairs Manager will also support abstract, poster and manuscript tracking and review for ISS studies and may occasionally support similar study management processes for Collaborative studies.

Requirements

• 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.

Nice To Haves

• 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

Responsibilities

• 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.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager