Country Study Operations Manager - FSP

• Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required
• Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required
• A scientific or technical degree is preferred

Originally posted on Himalayas

• Comprehensive knowledge of own discipline with good knowledge of other disciplines to ensure that the study can meet its goals and to serve as a resource for others
• Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team
• Working knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibility
• Demonstrated clinical research experience and/or study management/startup project manager experience
• Demonstrated experience in managing country level operational activities and/or vendors
• Experience in study and quality management

Knowledge of clinical trial methodology

• Experience working in a matrix management environment
• Relevant operational clinical trial experience

o See below Education section for minimum requirements

• Acts as the point of contact for all study level questions for the local study team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles and teams
• May lead operational effectiveness initiatives at country or regional level
• Utilizes roles in country such as Lead SCP, and expert roles such as Contracts Leads and SAPs, to provide the global teams with local intelligence and operational nuances to be considered
• Provides input on country level per subject costs, local vendor costs, and other fees where applicable
• Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan and Study Monitoring Plan, and ensures Trial Master File (TMF) completeness and oversight of all relevant compliance activities for allocated studies
• Supports implementation of client’s site technology experience systems
• Supports implementation of new tools and technologies (e.g., eConsent, eISF, remote source access, remote source data verification/review (SDV/SDR), iConnect, implementation of protocol required decentralized trial options)
• Complies with required training curriculum
• Completes timesheets accurately as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
• Expertise in the use of study and site dashboards and reporting tools
• Detail oriented and possesses technical expertise
• Ability to manage moderately complex processes
• Risk identification and mitigation, strategic planning, and critical path analysis skills
• Ability to adapt to changing technologies and processes, work independently and exercise own judgement
• Supportive of an environment where innovation is standard, including developing ideas and 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 operate in a matrix environment
• 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