[Hiring] Global Study Manager II @Parexel

Role Description

The Global Study Manager II (GSM II) provides operational leadership throughout the study lifecycle, with accountability for oversight and execution of study management, site management, preferred Contract Research Organization (pCRO), and vendor deliverables for all study management deliverables in a study.

The Global Study Manager has exceptional knowledge within the organization for Study Management processes and deliverables. Additionally, the Global Study Manager will maintain expertise within their assigned Therapeutic Area and study in order to set the appropriate strategy, identify risks and to drive operational deliverables.

The Global Study Manager will have good knowledge in understanding the responsibilities beyond their function in order to ensure goals are met for the study.

Key Accountabilities

• Leads and coordinates the execution of a clinical trial globally from sourcing strategy and study specification development for requests for proposals to fully outsourced studies and ancillary vendors.
• Provides quality oversight and coordination of regional and country operations and the pCRO for the tasks both owned by and delegated to Study Operational Managers (SOMs).
• Provides leadership to the teams in setting recruitment targets and delivery milestones.
• Serves as a critical member of the core team and represents the operational sub-team including applicable vendors and pCRO on matters of study execution.
• Drives decision making and works closely with the Clinical Study Team Lead (CSTL) to provide input to operational strategy.
• Provides supervision and/or mentorship to SOMs and possibly other GSMs.
• Ensures development of study level plans, including the study monitoring and study training plans.
• Develops, reviews, or approves the study startup, study monitoring, protocol recruitment, and training plans.
• Approves and oversees drug supply management, manages flow of drug supply to the sites.
• Ensures overall vendor oversight for vendors managed by SOMs.
• Reviews consolidated pre-trial assessment (PTA) reports and feasibility outputs.
• Ensures applicable system closure at study completion.
• May support study level submission readiness.
• May participate in vendor user accountability testing (UAT) and system setup requirements review and approval.

Qualifications

• Exceptional knowledge of study management processes and deliverables.
• Good knowledge in understanding the responsibilities beyond their function to ensure goals are met for the study.
• Maintains expertise within the assigned therapeutic area and study to set the appropriate strategy, identify risks and to drive operational deliverables.
• Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations.

Requirements

• 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 along with extensive knowledge of clinical trial methodology.
• 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 IMs, vendor kick off and re-set meetings, and client internal global or department level meetings.

Skills

• Requires exceptional knowledge of own discipline and advanced knowledge of others.
• Creates an environment where innovation is standard, taking appropriate risks to advance innovative processes.
• Develops ideas and leads complex projects across sub-business unit/sub-operating unit.
• Develops innovative solutions to complex problems impacting a sub-business unit/sub-operating unit.
• Exercises own judgment and is a resource for others.
• Acts independently on self-initiated projects.
• Experience in clinical research and/or study management.
• Study management/leadership experience.
• Experience with oversight of CROs and vendors.
• Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend.