Global Study Manager II - FSP

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is looking to hire multiple Global Study Managers in Argentina, Brazil or Mexico!

Job Summary 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:

Study Management Oversight

• 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, study start up through database release and inspection readiness to ensure timely delivery of quality study data. May also provide input to and support compilation of sections to clinical study reports (CSRs) as needed

• 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), if assigned to study, related to study execution

• Provides leadership to the teams in setting recruitment targets and delivery milestones as the single point of accountability for detailed study start up, monitoring, and other study level plans and delivery to the agreed plans by partnering with cross functional colleagues

• 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 and other documents, guidelines, and plans. May delegate development of plans or components of plans to SOMs (if assigned) or to Clinical Study Team Assistants (CSTAs) as appropriate

• Approves and oversees drug supply management, manages flow of drug supply to the sites, and sets up interactive randomization systems with supply chain lead

• Ensures overall vendor oversight for vendors managed by SOMs (if assigned), action escalations related to vendor issues and escalate further as necessary

• Reviews consolidated pre-trial assessment (PTA) reports and feasibility outputs in partnership with appropriate cross functional colleagues

• 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 a...