Remote Global Feasibility Manager

Summary

Join our A-team as a Global Feasibility Manager (Pre/Post Award) and contribute to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials. As a key member of the Global Study Start-Up and Site Intelligence department, you will produce and oversee recommendations for country and site selection strategies, enrollment projections, and subject recruitment strategies.

Requirements

• Bachelor's Degree in a life sciences field is required
• Masters Degree or Ph.D. in Healthcare or Biological Science is preferred
• Minimum of 5 years of experience in drug development and/or clinical research; or equivalent combination of education, training, and experience
• Minimum 5 years of Global Feasibility & Site Identification experience; experience in strategic feasibility preferred
• Basic knowledge of ICH-GCP, GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements
• Demonstrable experience with analytics involving large datasets

Responsibilities

• Provide input to proposals and business development to help build project assumptions, budget, and timelines (including overall recommendations on the countries, number of sites and projected number of patients)
• Identify and present regions where the disease is prominent to create an initial country pool to be further refined based on corporate experience, operational capabilities, medical input, and other feasibility considerations
• Identify the incidence and prevalence of the disease / syndrome
• Analyze competing clinical trial landscape in order to assess study feasibility and identify barriers for enrollment
• Access open source and proprietary databases to determine similar patient populations and or therapeutic classes of drugs under investigation
• Determine whether the countries proposed have comparator drug access/reimbursement. As appropriate, prepare tabular displays of this information for evaluation by the feasibility stakeholder pool
• Represent Allucent’s global or regional expertise by presenting our study footprint in the indication, which may include compiling corporate experience, and expertise in specific indication when needed
• Work with Allucent’s medical experts / KOLs on the conduct of the study as well as its acceptance and standard of care in target regions
• Collaborate with Global Study Start-Up to determine strategy, regulatory pathway and timelines associated with the conduct of the proposed study
• Conduct/oversee the conduct of post-award feasibility studies with potential sites as required, in order to select the most appropriate sites for the execution of Allucent studies
• Write or oversee the writing of feasibility reports for clients as required
• Present and explain feasibility analysis to BD/Clients (e.g. during bid defense meetings), including the process, recommendations and rationale
• Proactively provide input to clinical project teams on patient recruitment & retention strategies to prevent and mitigate recruitment issues
• Maintain internal libraries and databases related to feasibility
• Expand and maintain site and investigator network
• Assure the Feasibility function interfaces effectively with all other key operating departments within Allucent
• Review and approve reports and manuscripts, as necessary, within management structure

Benefits

• Comprehensive benefits package
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for fully remote/hybrid working
• Leadership and mentoring opportunities
• Internal growth opportunities and career progression
• More task variety
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms