Study Operations Manager II - FSP

at  Parexel

The Study Operations Manager II (SOM II) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks.

SKILLS:

• Expertise in the use of study and site dashboards and reporting tools
• Detail oriented and possesses technical expertise
• Ability to manage complex processes
• Risk identification and mitigation, strategic planning, and critical path analysis skills
• Analytical and problem solving skills
• Ability to adapt to changing technologies and processes
• Ability to create an environment where innovation is standard, including taking appropriate risks to advance innovative processes
• Effective verbal and written communication skills in relating to colleagues and associates, both inside and outside of the organization
• Ability to apply exceptional knowledge of own discipline and advanced knowledge of others to ensure that a Sub Business Unit/Sub Operating Unit meets its goals
• Ability to develop ideas and lead complex projects across a Sub Business Unit/Sub Operating Unit
• Ability to develop innovative solutions to complex problems impacting a Sub Business Unit/Sub Operating Unit
• Ability to work independently with assignments, often self-initiated, and to exercise own judgment
• Ability to manage in a matrix environment and to be a resource for others
• Fluency in written and spoken English required
• Ability to work outside of core business hours, as required, to support global trials or initiatives
• Ability to travel, as required, including Investigator Meetings, vendor kick off and re-set meetings, and client internal global or department level meetings

Knowledge and Experience:

• Knowledge of site selection, site activation, and site readiness interdependencies as well as clinical trial methodology and the drug development process
• Exceptional knowledge in managing and coordinating specific tasks and responsibilities as part of the larger study management team
• Working knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibility
• Extensive operational clinical trial experience
• See below Education section for minimum requirements
• Experience in clinical research and/or study management/startup project manager experience
• Knowledge of clinical trial methodology
• Experience participating on cross functional teams and working in a matrix management environment
• Project management and quality management experience

EDUCATION:

• Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial experience required
• Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required
• A scientific or technical degree is preferred

Please refer the Job description for details