Country Study Manager - FSP - East Coast

Location: Any Region, REMOTE, United States of America, Alabama, United States, Alaska, United States, Arizona, United States, Arkansas, United States, California, United States, Colorado, United States, Connecticut, United States, Delaware, United States, Florida, United States, Georgia, United States, Hawaii, United States, Idaho, United States, Illinois, United States, Indiana, United States, Iowa, United States, Kansas, United States, Kentucky, United States, Louisiana, United States, Maine, United States, Maryland, United States, Massachusetts, United States, Michigan, United States, Minnesota, United States, Mississippi, United States, Missouri, United States, Montana, United States, Nebraska, United States, Nevada, United States, New Hampshire, United States, New Jersey, United States, New Mexico, United States, New York, United States, North Carolina, United States, North Dakota, United States, Ohio, United States, Oklahoma, United States, Oregon, United States, Pennsylvania, United States, Rhode Island, United States, South Carolina, United States, South Dakota, United States, Tennessee, United States, Texas, United States, Utah, United States, Vermont, United States, Virginia, United States, Washington, United States, West Virginia, United States, Wisconsin, United States, Wyoming, United States, Remote

Employment Type: Remote

Job Summary:

The Country Study Manager is responsible for the execution of study-level activities including but not limited to creating and updating trial-specific documents, vendor oversight & delivery, compound training and country and regional oversight of CRO operational delivery. This includes alignment on the feasibility strategy, target setting, risk reviews, and country challenges that could impact overall study delivery.

Key Accountabilities:

• Manage integration of project team activities

• Manage strategic study operations including but not limited to study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, budget and financial information, performance metrics, and data flow

• Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specific studies

• Provide input into global subject/patient recruitment plans

• Manage aspects of CRO/vendor identification and the day-to-day operational management activities of CROs and other vendors including set up, statement of work creation, and budget oversight

• Create and update critical trial-specific documents

• Support development of compound and protocol level training materials

• Review and provide input into budgets, timelines, and forecasts for assigned clinical studies

• Provide support for inspection readiness activities including risk identification and mitigation plans at the trial level

• Participate in process improvement activities at a trial and department level as needed
• Manage relationships between study sites and vendors
• Interface with internal key stakeholders
• Support onboarding of new team members
• Attend stakeholder meetings and provide input and updates on operational activities and progress

Skills:

• Excellent decision-making, analytical, and financial management skills
• Excellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision
• Experience in leading without authority and in multifunctional matrixed and global environments
• Experience mentoring and coaching others
• Exceptional organizational skills and ability to deal with competing priorities
• Strong reasoning and problem-solving abilities
• Strong project planning/management, communications (written and verbal) and presentation skills
• Experience with protocol, informed consent form (ICF), case report form (CRF), and clinical study report (CSR) development and review
• Proficient in MS Office Suite (Excel, Word, and PowerPoint)
• Ability to travel approximately 10%

Knowledge and Experience:

• Minimum 5+ years of clinical research experience gained with a CRO, biotech or pharmaceutical company working on phase I-IV global clinical trials
• 2-3 years leading aspects of global clinical trials
• Experience working with CROs

Education:

• Bachelors degree is required

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