Covance is recruiting for a Global Study Manager to be client-dedicated within the Oncology Department of one of our clients. This role will be based out of a Helsinki office so candidates need to live in the Capital area of Finland.
As a core member of the Study Team, the Study Lead Monitor works in close collaboration with the Study Manager and the study team. The SLM leads and manages globally dispersed Country Lead Monitors and Clinical Research Associates for the assigned clinical trials. Although the CLMs and CRAs report functionally into their Line Management, the SLM manages the study-related CLM and CRA activities.
The SLM is responsible for overseeing all operational aspects of Monitoring and Site Management activities for the assigned Phase II-IV clinical trials for the client's Global Clinical Development and Global Medical Affairs.
- Advisor to Study Team as expert in all operational aspects of conducting a clinical trial
- Verifies study processes and expectations correspond to the practicality of conducting the trial from the operational perspective, from study feasibility to study close out.
- Leads and manages the assigned Country Lead Monitors (CLMs) and CRAs globally, overseeing the operational conduct and quality oversight of the study from the global perspective.
- Reviews Country Monthly Reports, tracks operational study activities and progress, proactively identifies issues and escalates appropriately to see that timely corrective and preventive actions are taken. Consolidates Country Monthly Reports for Study Manager.
- Supports the StM in operational feasibility process and organization of the feedback from the countries
- Collaborates with Site Management Organization to develop Monitoring and Site Management component of the Operational Quality Oversight Plan and, if required, Data Verification Initiatives.
- Conducts co-monitoring visits and reviews Periodic Monitoring Visit Reports according to the Operational Quality Oversight Plan. Is an active member of the Fraud & Misconduct Team and/or Inspection Team, if applicable.
- Responsible and accountable for developing the study specific Monitor Training Plan and Investigator Site Training Plan. Obtains requisite functional and legal/compliance approvals and coordinates activities related to multi-center Monitor and Investigator Site Training meetings. Accountable for developing Monitor Training materials, ensuring study specific training of Monitors, training new Monitors to the study and reviewing and approving training content changes. Develops Investigator and Site staff training material for functional and operational study activities. Makes presentations as assigned at Investigator Site and/or Monitor Training as assigned.
- Responsible and accountable for developing the Study Monitoring Plan, Enrollment plan and determining Investigator delegation responsibilities for the study and obtains requisite functional approvals. Develops training material and training plan to see that all Monitors assigned to the study have a thorough understanding of the Monitoring Plan and study expectations.
- Contributes to the protocol, study plan and other operational plans development with regard to its monitoring operational aspects
- Works in close collaboration with Study Data Manager (SDM) to oversee consistent monitoring and data management objectives for the trial. Member of the Study Data Acquisition and Management Package Development Team (SDAMP-DT) and works closely with the EDC Developer in developing the eCRF, edit checks and eCRF instructions. Coordinates GMSM User Acceptance Testing and system access for Monitors and Investigator Site Staff. In partnership with SDM, tracks and manages patient data cleaning process to oversee continuous and current flow of data cleaning.
- Above responsibilities are applicable for all internally monitored clinical trials.
- For outsourced trials, the SLM is the primary contact with CLMs, CHSM and Country Medical Directors, verifies applicable information is cascaded in a timely manner and verifies required country reviews of applicable documentation. In addition, the SLM:
- Reviews study specific Monitor and Investigator Site Staff Training Plans and Investigator Meeting Approval Forms, obtaining requisite functional and legal/compliance approval.
- Reviews Study Monitoring Plan, the relevant CRO plans and verifies plan is consistent with expectations.
- Oversees Operational Quality Oversight Plan by conducting co-monitoring visits, overseeing co-monitoring visits, reviewing Monitoring Visit Reports, etc. as defined in the Operational Quality Oversight Plan. Escalates operational issues or potential issues to StM as applicable.
Other Information: This role is a full time & permanent position to be employed through Covance. For more information please contact Andy Smith at Covance on +44 (0)7775 848 250 or mail email@example.com
International Clinical Project Manager, Finland, Helsinki, Espoo, Senior Clinical Study Manager, OncologyEducation/Qualifications:
Bachelor's degree or equivalent.Experience:
7 years of relevant Healthcare experience with 5 years of direct monitoring experience in the Pharmaceutical Industry. This position requires in-depth knowledge of ICH-GCP and international regulations. This position also requires awareness and understanding of cultural differences as well as regional operational differences.
Global / Regional CTL experience is required and candidates must have Oncology experience in their current or previous roles.
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