Global Feasibility Manager

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Requirements:

• Experience in pre and post-award preferred.
• 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/HIPAA, CFR/CTR/CTD and applicable (local) regulatory requirements.
• Demonstrable experience with analytics involving large datasets.
• Strong written and verbal communication skills including good command of the English language.
• Representative, outgoing and client focused.
• Demonstrated knowledge of government/international databases or proprietary databases (e.g., PubMed/Medline, ClinicalTrials.gov, Citeline).
• Ability to interpret data sources and translate information into usable recommendations.
• Demonstrated ability to form strong working relationships with other groups within the organization.
• Ability to work in a fast-paced challenging environment.
• Administrative excellence.
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required.

Responsibilities:

• Provide input to proposals and business development to help build project assumptions, budget, and timelines.
• Identify and present regions where the disease is prominent to create an initial country pool.
• 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.
• Determine whether the countries proposed have comparator drug access/reimbursement.
• Work with Allucent's medical experts/KOLs on the conduct of the study as well as its acceptance and standard of care.
• Collaborate with Global Study Start-Up to determine strategy, regulatory pathway, and timelines associated with the proposed study.
• Conduct/oversee the conduct of post-award feasibility studies with potential sites.
• Write or oversee the writing of feasibility reports for clients as required.
• Present and explain feasibility analysis to BD/Clients.
• Proactively provide input to clinical project teams on patient recruitment & retention strategies.
• Maintain internal libraries and databases related to feasibility.
• Expand and maintain site and investigator network.