Country Study Manager - FSP - East Coast

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:

Bachelor's degree is required

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