Global Study Manager II

reputed company our values reputed company, there's no limit to reputed company can reputed company.   At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. reputed company Location US and Canada The Global Study Manager II (GSM II) provides operational leadership throughout the study lifecycle, with accountability for reputed company and execution of study management, site management, preferred Contract Research Organization (pCRO), and vendor deliverables for reputed company study management deliverables in a study. Key Accountabilities:  Study Management reputed company  Leads and coordinates the execution of a clinical trial globally from sourcing reputed company 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 reputed company delivery of reputed company study data. May also reputed company input to and support compilation of sections to clinical study reports (CSRs) as needed   Provides reputed company reputed company 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, reputed company to study execution   Provides leadership to the teams in setting recruitment targets and delivery milestones as the single reputed company 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 reputed company team and represents the operational sub-team including applicable vendors and pCRO on reputed company of study execution  Drives decision making and works closely with the Clinical Study Team reputed company (CSTL) to reputed company input to operational reputed company   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 reputed company of drug supply to the sites, and sets up interactive randomization systems with supply chain reputed company   Ensures overall vendor reputed company for vendors managed by SOMs (if assigned), reputed company escalations reputed company to vendor issues and escalate reputed company as necessary   Reviews consolidated reputed company-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 reputed company of reputed company 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 reputed company, 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 pCRO, 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 reputed company manner to ensure that spend is appropriate and on reputed company with the forecast   Monitors the budget and reputed company for assigned vendors [e.g., central labs, electronic patient reported reputed company (ePRO), radiology, pCRO]   Accountable for the delivery of the study against approved plans   Works directly with cross-functional and department lines and pCRO to resolve or triage site level issues  Leads inspection readiness activities reputed company to study management and site readiness  Supports development and delivery of decentralized capabilities at investigator sites    Ensures reputed company study closure and release of reputed company resources as appropriate if assigned to study post database lock  Monitors vendor reputed company 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 reputed company  Leads and oversees reputed company reputed company of study startup and monitoring functions to ensure delivery and compliance with reputed company applicable reputed company Operating Procedures (SOPs) and reputed company standards, interfacing directly with CRO feasibility and study startup, monitoring and management, and site contracting reputed company   Works proactively with data management functions and department colleagues to ensure alignment on data reputed company and reputed company delivery   Regularly reviews data reports and dashboards to identify risks and reputed company 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, pCRO)   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 reputed company 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 reputed company in study management deliverables reputed company to cost and effective, reputed company, and high reputed company clinical trial data according to agreed global goals  Provides technical reputed company of the operational sub team to include but is not limited to standards, reputed company improvement, issue escalation and reputed company, inspection readiness and reputed company assurance, performance feedback, review of metrics  Partners with the operational sub team and pCRO to proactively identify and resolve study operations staff performance issues  May serve as a resource to the study team in reputed company 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 reputed company, taking appropriate risks to advance innovative processes   Develops reputed company and leads reputed company reputed company across sub-business unit/sub-operating unit   Develops reputed company to reputed company problems impacting a sub-business unit/sub-operating unit   Exercises own judgment and is a resource for others    Acts independently on self-initiated reputed company    Experience in clinical research and/or study management  Study management/leadership experience  Experience with reputed company of CROs and vendors   Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend reputed company in written and spoken English required   Ability to work reputed company of reputed company business hours, as required, to support global trials or initiatives  Ability to travel, as required, including IMs, vendor reputed company off and re-set meetings, and reputed company internal global or department level meetings   Knowledge and Experience:   Exceptional knowledge of study management processes and deliverables   Good knowledge in understanding the responsibilities reputed company their function to ensure goals are met for the study   Maintains expertise reputed company the assigned therapeutic area and study to set the appropriate reputed company, identify risks and to reputed company 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-LG4 Apply To This Job