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Vacancy details
Vacancy description:
Job Code:
PN 1653
Job Title:
Senior Study Manager
Job Category:
Clinical Research
Contract:
Permanent
Discipline:
Any Discipline
Country:
United Kingdom
Location:
Kent
Min experience:
N/A
Annual salary:
Negotiable (50000 - 55000 £)
Apply by:
02 Sep 2008
Leading a group of study managers and CTAs, the senior study manager is responsible for delivering the operational aspects of one or more clinical studies from protocol feasibility through database release. Their primary deliverable is high-quality, timely and cost-effective data. The senior study manager also contributes beyond database release to support effective study reporting and close-out; submission activities; and audits/inspections, as appropriate.
The senior study manager achieves this purpose by coordinating the activities and deliverables of all study conduct partners (Study Managers, U.S. region & Country Offices, Pharm Sci, Vendors) and by proactively identifying and managing issues.
The senior study manager will be responsible for leading a large multi-country trial requiring multiple SMs & CTAs as required.
Responsible for liaising with members of the project team to include but not limited to: Clinical Protocol Manager (CPM), SCC, Lead DM, Lead CPW, Clinician, C&O, U.S. region and PCO CPMs.
Will also liaise with Program Study Manager (PSM) for technical system and process expertise and TA operational knowledge.
The Role:
• Coordinate the activities and deliverables of all study conduct partners (Study Managers, U.S. region & Country Offices, Pharm Sci, Vendors) to ensure timely delivery of quality data on one or more studies.
• Oversee U.S. region & Country Offices to ensure that protocol and Monitoring Plan are consistently and appropriately implemented across investigator sites and countries. Collaborate with the U.S. region & Country Offices to ensure they are provided with the information to effectively contribute to the study.
• Proactively identify and resolve study operations-related issues as they arise.
• Responsible for ensuring that the operational aspects of a clinical study meet time, quality & cost targets consistent with the Clinical Development Plan.
• Responsible for ensuring that studies are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; responsible for study management components of inspection readiness for all aspects of the study conduct.
• Assist CPM to develop project plans and implement resource strategies to achieve team’s project goals, including contingency planning and risk mitigation strategies, to ensure successful delivery of study goals.
• Support the efficient implementation and utilization of globally agreed, processes, technologies and strategies (e.g., SDVSS, IVRS, etc).
• May coach and mentor other study managers as appropriate.
Budget
• Liaise with C&O to initiate, review and approve study management components of study start-up budget, including per subject and ancillary investigator costs, and clinical trial budget.
• Approve up front or initial payments to sites.
Data Management/GCDS Interactions
• Liaise with LDM and protocol team in the design of data capture tools (CRFs, EDC system, diary cards, questionnaires, translations etc), review and approval of database design, and agreement on data quality requirements to ensure completion within project deliverable timelines.
• Contribute to the review of the database and associated design, data acquisition timelines, data quality requirements to ensure contemporaneous data quality and availability to support interim analyses and/or database lock timelines to agree project delivery timelines.
• Work with LDM on the development and implementation of DQMP.
Subject Recruitment/Country Allocation/Site Selection/Start-up (as appropriate)
• Conduct country level allocation including initiating country and study level feasibility assessments to ensure appropriate country and study site selection.
• Develop study level recruitment/retention strategy/plan (including contingency and site closure plans); oversee implementation of plan, including site-level plans, recruitment/retention tools, and advertising materials.
• Oversee U.S. region & Country Offices to ensure timely site selection and site readiness (Clinical Trial Agreements, Ethics Committee approvals and regulatory documentation.).
• Create study level enrollment targets in Clinrepnet Targets & Forecasting tool (protocol and country level).
• Ensure country monitoring agreements are finalized with each country for their reimbursement.
Training/Investigator Meeting (as appropriate)
• Together with country representatives (U.S. region & Country Offices) develop the Monitoring Plan.
• Ensure U.S. region & Country Offices are trained on protocol-specific aspects of the Monitoring Plan.
• Responsible for working with the Clinician to ensure that monitoring lines are provided with appropriate training in both the protocol and therapeutic area.
• Organize the investigator meeting including developing the agenda.
• Responsible for overseeing implementation of the investigator meeting by the appropriate groups (e.g., Meeting Planning group, U.S. region & country offices).
• Liaise with protocol team to develop Investigator Meeting objectives and associated materials.
• Facilitate and present at investigator meetings, as required by project team.
Drug Supply
• Work with the Supply Chain Coordinator to ensure that clinical trial drug supplies are labeled and supplied in a timely manner, including coordination of translations.
Vendor Management
• Support study team with Vendor selection and management.
• The postholder will perform necessary functions and as directed, any other duties commensurate with the post to ensure the smooth running of operations within the location(s).
Experience:
• International clinical trial experience desirable.
• Previous study management experience.
• Demonstrated effectiveness in working in a multidisciplinary, matrix team situation
• Direct therapeutic area expertise is required.
• Understanding of scientific/clinical principles and ability to work across different therapeutic areas.
• Ability to instill customer confidence in ability to deliver to project deliverables.
• Extensive knowledge of clinical development process including in depth knowledge and understanding of the principles of GCP.
• Ability to communicate effectively and appropriately with internal staff and investigator sites.
• Knowledge of the clinical development process, understand concepts of Phase I-IV and principles of study design. Experience in all phases of the clinical trial including study start, conduct and reporting.
• Working knowledge of data management processes and principles, including CRF design and query management.
• Knowledge/understanding of technologies to support data acquisition including EDC and data validation.
• Disciplined approach to document maintenance and management.
• Extensive knowledge/understanding of clinical trial management, and awareness of CFR 21 Part 11.
• Ability to organize tasks, time and priorities of self and others; ability to multi-task.
• Ability to manage studies and processes to agreed quality and timelines.
• Risk management and contingency planning expertise required.
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization.
• Ability to proactively communicate project issues and actions to mitigate risk and to ensure project members are aware of study status at all times.
Qualifications:
• Minimum of BS/BA in a biomedical discipline or equivalent education/training is required.
PLEASE NOTE: IF YOU HAVE NOT HEARD FROM US WITHIN 2 WEEKS OF APPLYING FOR THIS POSITION, UNFORTUNATELY ON THIS OCCASION YOU HAVE NOT BEEN SUCCESSFUL.
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