Clinical Project Manager

Our Company

NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and has a strong executive team with rich industry experience. NIT is expanding rapidly in personnel and operations, as well as partnering with industry and academic leaders to investigate NT-I7 as monotherapy and in combination with various immunotherapeutics.

We Offer

• Hybrid work opportunity
• Competitive pay
• 401(k) + company matching - 100% vests immediately!
• Medical insurance
• Flexible Spending Account (FSA)
• Life insurance
• Paid Time Off
• Paid holidays
• Paid family medical leave
• Free lunches, snacks, and drinks
• Cell phone reimbursement
• Internet reimbursement
  
  

Responsibilities

• Lead and manage large, complex trials and/or multiple smaller trials to deliver positive patient and investigator site experiences and high-quality data
• Partner with other organizations to oversee and actively participate in Site Initiation Visits (SIVs), Investigator Calls and Investigator Meetings
• Responsible for enrollment strategy
• Responsible for trial documentation and ensuring inspection readiness of respective clinical trial(s) at all times. This includes timely documentation of deviations, creation of storyboards or issue summary documents (e.g., high-risk areas/hot topics)
• Lead vendor (including CRO) qualification process, selection, and oversight
• Manages review and negotiation of trial budgets, contracts, and invoices in collaboration with cross-functional team members as applicable
• Applies expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Company standards of operation in the conduct of clinical trials
• Work closely with Clinical Scientist/Clinical Lead and other cross-functional team members to develop study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference binders, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, Clinical Study Report (CSR), etc.
• Responsible for management of data management and clinical operations teams in review of clinical data including providing guidance on issues/queries as needed and implementing risk management concepts
• Responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory document/packages
• Conduct sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP, corporate SOPs and protocol as needed
• Create, manage, and report timelines for milestone and deliverables
• Other tasks assigned by Senior Director, Clinical Operations
  
  

Qualifications

• Experience in management of Oncology trials or pediatric trials preferred
• Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)
• At least 3 years’ previous experience in study coordination (e.g., study site) or study management (e.g., CRO or sponsor)
• Fluency in study phases and demonstrable knowledge of how they apply to clinical development
• Strong working knowledge of ICH Good Clinical Practice guidelines
• Working knowledge of project management concepts (e.g., scope, resources, timeline, risk management)
• Able to handle multiple tasks and deadlines
• Self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
• Able to identify issues and take appropriate actions
• Excellent verbal and written communication skills
• Experience using computer applications including spreadsheets, email, word-processing software and web-based systems
  
  

NeoImmuneTech, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

If you require assistance to complete a job application, please email us at hr-us@neoimmunetech.com.