Global Study Manager/Project Leader - US or Canada - FSP

About the role

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. 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 (CRO), and vendor deliverables for all study management deliverables in a 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 CRO 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 CRO 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 approval [e.g., Interactive Response Technology (IRT), central lab]  Study Management Operations   Accountable for study management and oversight of all study management functions   Forms, oversees, and leads the operational sub team and requests resources as needed   Ensures the development of realistic detailed study startup and/or study management strategies and monitoring plans, including sourcing strategy, input into requests for proposals, and for the selection of vendors   Ensures country level feasibility is completed in collaboration with cross functional departmental colleagues, organizations, and CRO, reviewing PTA report outputs, approving sites, and assessing site activation plans   Ensures Trial Master File (TMF) setup for study management and country and site level documents   Provides input into the risk planning process for the study   Coordinates development of study and protocol training and global investigator meetings (IMs)  Ensures that local IMs are coordinated by the SOM, if assigned to study  Develops and provides key inputs to clinical trial budget (e.g., per subject costs)   Ensures that SOMs are inputting into the budget for local/country level tasks (if assigned), and reviews cost variance, invoices, and purchase orders (POs) in a timely manner to ensure that spend is appropriate and on track with the forecast   Monitors the budget and contracts for assigned vendors [e.g., central labs, electronic patient reported outcomes (ePRO), radiology, CRO]   Accountable for the delivery of the study against approved plans   Works directly with cross-functional and department lines and CRO to resolve or triage site level issues  Leads inspection readiness activities related to study management and site readiness  Supports development and delivery of decentralized capabilities at investigator sites    Ensures timely study closure and release of internal and external resources as appropriate if assigned to study post database lock  Monitors vendor contracts for out of scope activities and budget spend and invoices for assigned vendors (e.g., central labs, ePRO, radiology)  Reviews study level metrics and analytics and ensures appropriate actions are taken to mitigate risks and resolve issues  Works independently and demonstrates resourcefulness  May, on occasion, take on the role and responsibilities of a SOM  Study Team Interface   Leads and oversees all elements of study startup and monitoring functions to ensure delivery and compliance with all applicable Standard Operating Procedures (SOPs) and quality standards, interfacing directly with CRO feasibility and study startup, monitoring and management, and site contracting groups   Works proactively with data management functions and department colleagues to ensure alignment on data flow and timely delivery   Regularly reviews data reports and dashboards to identify risks and drive appropriate actions   Shares and escalates plan deviations to CSTL and study team and drives and oversees mitigations   Review vendor expenses and workorders as per study budget for assigned vendors (e.g., central labs, ePRO, radiology, CRO)   Provides ongoing assessment of subject enrollment and discontinuations to inform accurate forecasting for financial planning   Provides operational input into protocol design   Leads protocol deviation trend review, partnering with the clinical team   May lead and facilitate the routine study management vendor calls  Subject Matter Expertise   Serves as technical expert for study management systems and processes  Champions the implementation and use of harmonized, consistent processes, and excellence in study management deliverables related to cost and effective, timely, and high quality clinical trial data according to agreed global goals  Provides technical oversight of the operational sub team to include but is not limited to standards, continuous improvement, issue escalation and resolution, inspection readiness and quality assurance, performance feedback, review of metrics  Partners with the operational sub team and CRO to proactively identify and resolve study operations staff performance issues  May serve as a resource to the study team in addition to the SOM(s), if assigned, to facilitate project specific audits and inspections  Skills:    Requires exceptional knowledge of own discipline and advanced knowledge of others and applies these skills to ensure a sub-business unit/sub-operating unit meets its goals   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 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   Knowledge and Experience:    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   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 along with extensive knowledge of clinical trial methodology #LI-LO1 EEO Disclaimer Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.