Pfizer Slovakia Slovakia
3 weeks ago
Global Study Managers provide operational leadership throughout the study lifecycle, with accountability for oversight and execution of study management, pCRO and vendor deliverables for all Study Management deliverables in the study.
The Global Study Manager is a recognized expert 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 be an expert in understanding responsibilities beyond their function to be able to influence the strategy and challenge the status quo where needed to meet and exceed timelines and quality deliverables for Study Management.
• Manage and lead studies of key importance to the business and the portfolio. They will lead and manage the tactical execution of a large... and/or highly complex clinical study from study startup through database lock and possibly up to Clinical Study Report (CSR).
• Make thoughtful and complex decisions and judgements while understanding the larger impacts to those decisions. The Global Study Manager will be able to offer multiple solutions and innovative options in mitigating risks and solving problems.
• Leads and coordinates the execution of a clinical trial globally from Sourcing Strategy and Study Specification development for Requests for Proposals for fully outsourced studies and ancillary vendors, Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data.
• Provides quality oversight and coordination of regional/country operations and pCRO for the tasks both owned by and delegated to Study Operational Managers (if assigned to study) related to study execution.
• Provide leadership to the teams in setting recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring and other study level plans and delivery to the agreed plans.
• Provide supervision and/or mentorship to Study Operational Managers.
• Monitor vendor contracts for out of scope activities and budget spend/invoices for assigned vendors.
• Responsible to ensure development of study level plans.
• Responsible to review study level metrics and analytics and ensure appropriate actions are taken to mitigate risks and resolve issues.
• Demonstrated clear ability to operate independently, appropriately manage escalations and closure of issues while demonstrating resourcefulness and ability to support other roles in a matrix environment.
• The Global Study Manager may need to on occasion take on the role and responsibilities of a Study Operational Manager.
Training and Education
• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
• A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology.
• BA/BS 10+ years of relevant experience
• MBA/MS 9+ years of relevant experience
• Ph.D. 5+ years of relevant experience
English is required.
• Demonstrated extensive global clinical trial/study management experience
• Demonstrated study management/leadership experience
• Demonstrated oversight of CROs/vendors
• Demonstrated experience in managing per subject costs, vendor & ancillary, and monitoring costs projections & spend
• Is recognized as an expert within the organization, both within and beyond own function and applies this to influence the strategic direction of a Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit
• Promotes innovation and takes appropriate risks to challenge the status quo
• Leads unique and complex projects with influence across a Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit
• Identifies multiple solutions or innovative options in solving highly complex problems with direct impact on a Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit
• Exercises foresight and judgment in making complex decisions. Acts independently on self-initiated projects
Non-standard Work Schedule, Travel Or Environment Requirements
Travel may be required, including Investigator Meetings, Vendor Kick Off Meetings and Vendor Re-set Meetings. In addition, Study Manager also expected to travel to global-GSSO or department-level meetings.
Global Study Managermay be required to work outside of core business hours to support global trials or initiatives.
Work Location Assignment: Remote
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Global Study Manager Slovakia jobs
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