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. 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. Support development of compound and protocol level training materials 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 Ability to travel (approximately10% but flexibility to go over or below as per business need. BS/ BA Degree is required. Proven clinical research experience gained with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-4 global clinical trials. Demonstrated success 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)
