Associate Director, Clinical Operations

Job Description - Associate Director, Clinical Operations (240041) Associate Director, Clinical Operations ( Job Number: 240041 ) Summary of Key Responsibilities Lead and manage integration of all project team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources.
Manage performance, development and growth of junior staff to support and guide them to improved efficiency and effectiveness.
Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies.
Provide leadership and input into global subject/patient recruitment plans.
Effectively communicate and interact with Key Opinion Leaders.
Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and operational management activities of CROs.
Manage strategic study operations including study sites, tracking systems for regulatory submissions, CRO KPIs, drug supply, enrollment of subjects, regulatory document flow, study timelines, and budgetary information.
Participate in Case Report Form design and user acceptance testing in partnership with data management.
Generate country specific Informed Consent Form(s).
Lead the development of contingency/risk management plans for projects and assist in the preparation and execution of sound development strategies.
Provide support to clinical trial managers within and/or across programs.
Prepare budgets, timelines, and forecasts for clinical studies.
Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance, Clinical Research, Commercial, Regulatory, and Medical Affairs.
Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.
Ability to travel (no more than an annual average of 20%).
Qualifications Bachelor's Degree is required.
An advanced degree in a scientific and/or business/finance discipline is preferred.
8+ years of clinical research experience with a Biotechnology or Pharmaceutical Company working on later stage (Phase 2-4) multinational clinical studies.
2+ years clinical project management experience with global clinical studies.
Proven experience in effectively leading teams and managing direct reports.
Strong regulatory knowledge, including Good Clinical Practices (GCPs).
Exceptional organizational skills and ability to deal with competing priorities.
Excellent communication (written and verbal) and presentation skills along with leadership qualities.
Knowledge of global clinical trial management in a fast-paced CRO outsourced environment.
Apply project management best practices to programs.
Experience in novel clinical drug development.
Experience with protocol, ICF, CRF, CSR development and review.
Proficient with MS Office Suite (Excel, Word, and PowerPoint) and MS Project.
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