Summary of Key Responsibilities

• Manage integration of project team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.

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

• Provide input into global subject/patient recruitment plans.

• Relationship management between study sites and vendors

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

• Manage strategic study operations including:  study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc.

• Create and update critical trial-specific documents (for example country specific ICF) and plans

• Support development of compound and protocol level training materials

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

• Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Clinical Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.

• Provide support for inspection readiness activities and on identification of risks and mitigation plans at the trial level

• Participate in process improvement activities at a trial and department level as needed

• Support onboarding of new team members

• Attend CTWG and provide input and updates on operational activities and progress

• Ability to travel (approximately10% but flexibility to go over or below as per business need.

Qualifications

• BS/ BA Degree is required.

• 5+ years of clinical research experience gained with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-4 global clinical trials. 

• 2-3+ years leading aspects of global clinical trials

• Experience working with a CRO

• Strong regulatory knowledge, including Good Clinical Practices (GCPs)

• Strong decision-making, analytical and financial management skills are essential to this position

• 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/ coaching others

• Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.

• Strong project planning/ management, communication (written and verbal) and presentation skills

• Experience with protocol, ICF, CRF, CSR development and review.

• Proficient with MS Office Suite (Excel, Word and PowerPoint)