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All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The Study Manager has responsibility for all study management aspects of assigned studies.
The Study Manager leads and manages the tactical execution of one or more large and/or highly complex (multiple number of countries and sites with large number of subjects and/or high number and complexity of vendors and/or novel or rare patient population) clinical studies from study startup through database release.
The Study Manager provides quality oversight to the Clinical Research Organisation (CRO) and of the CRO deliverables related to study execution. The Study Manager leads and coordinates the execution of a clinical trial from Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data. Study Managers may also input to and support compilation of sections to Clinical Study Reports and provide program level insights. The Study Manager will provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans.
The Study Manager is a core member of the Study Team and will represent the CRO on matters of study execution.
The Study Manager works with functional lines and directly with CRO line functions to resolve or triage site level issues.
The Study Manager will drive decision making and work closely with the Clinical Project Manager to provide input to operational strategy.
For studies where more than 1 Study Manager is assigned may be required to act as 'lead' study manager and will coordinate activities of the other Study Managers assigned.
May be required to provide supervision and/or mentorship to other study managers
Responsible for Study Management and oversight of all Study Management functions internally and at the CROs
Operational Study Management
• Accountable for the development of realistic detailed study startup and monitoring plans
• Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs , approving sites, and assessing site activation plans
• Leads study risk planning process in context of site and subject
• Coordinates study/protocol training & investigator meetings
• Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
• Accountable for the delivery of the study against approved plans
• Leads inspection readiness activities related to study management and site readiness
• May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate
• May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.)
Study Management Oversight
• Approves the Study Startup, Study Monitoring & protocol recruitment plans
• Approves & oversees drug supply management - manages flow of drug supply to the sites & set up Interactive Randomisation Systems with Supply Chain Lead
• Reviews consolidated Pre-trial Assessment reports, feasibility outputs, etc.
• May support study level submission readiness
Study Team Interface
• Leads and oversees all elements of study startup and monitoring functions both internally and at the CROs to ensure delivery & compliance with all applicable Standard Operating Procedures and Quality Standards, interfacing directly with CRO Feasibility / Study Startup, Monitoring / Management & Site Contracting Groups
• Works proactively with CRO and data management functions to ensure alignment on data flow and timely delivery
• Shares and escalates plan deviations to Clinical Project Manager (and study team)
• Provides ongoing assessment of subject enrollment / discontinuations to inform accurate forecasting for financial planning
• Provides operational input into protocol design
Subject Matter Expertise
• The Study Manager will be the technical expert for study management systems and processes
• The Study Manager will champion the implementation and use of harmonized, consistent processes and excellence in Study Management deliverables related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals.
• The Study Manager will be responsible for the technical oversight of the CRO to include but is not limited to: mentoring, standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, review of metrics.
• The Study Manager partners with CRO Managers to proactively identify and resolve study operations staff performance issues.
• For project-specific audits and inspections, the Study Manager can serve as a resource to the study team to facilitate the audit/inspection.
Training and Education:
• Extensive global clinical trial/study management experience
• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
• BS/Nursing Degree - minimum of 7 years relevant experience
• MS/PhD - minimum of 5 years relevant experience
• Demonstrated study management / leadership experience
• Demonstrated oversight of CROs
• Demonstrated experience in managing per subject costs, vendor & ancillary, and monitoring costs projections & spend
• Understands how to work with vendors to accomplish tasks
• Ability to interpret study level data & translate and identify risks
• Ability to proactively identify & mitigate risks around site level in study execution
• Understands feasibility of protocol implementation
• Country level cultural awareness and strong interpersonal skills
• Keen problem solving skills
• Excellent communication skills, both written and verbal Must be fluent in English.
• Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management)
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This position will be required to work closely with colleagues in UK and USA, and this may include out of hours meetings for applicants in different time zones.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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