Well-known International Pharmaceutical Company is looking for a Study Manager to support its study team based in Spain. Focused on early development (phase I / first in human trials) in oncology and hematology our client manages international trials (worldwide).
The role of the Study Manager (SM) is to provide leadership in clinical trial activities, leading one or several cross functional study teams to deliver clinical research studies on time, within budget and with good quality in compliance with Regulatory Authorities regulations. The position requires an active role in developing the plan and monitoring of both manpower and clinical trial so that all aspects of the plan are in progress, sharing best practices and contributing to process improvement initiatives.
Responsibilities & duties
o Supervise research staff and ensure that they are reviewed regularly, remain relevant and adhered to.
o Lead cross-functional study team and/or sub-team, develop, manage and maintain study timelines, minutes, and budget and tracking, develop training materials and coordinate training on study procedures, develop study management plan.
o Accountable for site activities including site timelines, study visits, site selection, site initiation, site management, budget and tracking, study drug management and closeout activities
o Recommend policies, procedures and processes to ensure high level of QC and QA
o Manage ongoing communication of operation issues and provide accurate progress reports on assigned activities to study team
o Responsible for managing site and/or vendor budget activities as well as recommend vendors, review and approve vendors’ invoices.
o Participation in synopsis, protocol development and review, CRF design, project plans and clinical report writing, recommend number of investigative sites, oversee the development of investigational product supply forecasting and management, input on project specifications and feedback on requirements for CTMS, and oversee set up TMF.
o Develops reviews and approves regulatory and other required study documents for GCP compliance
o Contributes to projects that support wider organizational goals
o Participate in country selection, identify prospective investigative sites, review feasibility, participate in final sites selection, oversee negotiation of financial terms of individual site budgets, manage site payments, and monitor GCP/ICH site level compliance.
o Review essential regulatory documents, prepare study timeline, develop risk management plan, prepare, review and approve Monitoring Plan, review eCRF, review CRF completion guidelines, review and approve study tools, create study team contact roles and responsibilities, facilitate Development and Review of Data Review Plan.
o Provide input in Clinical Databases, review and report safety reports, participate in SAE reconciliation and review CSR Reports. Review edit specifications, execute EDC user acceptance testing scripts, and facilitate development and review of clinical data review plan, review summary reports, CSR review, oversight of safety report distribution to investigators, study team and ECs as applicable. Participate in SAE reconciliation.
o Prepare and review material for investigator meeting and CRA training, oversight of country regulatory approvals, oversee country/site EC approval, review regulatory package, obtain country/site insurance, authorize investigational product shipment, review and approve informed consent forms.
o Ensure enrolment is tracked and recorded, update recruitment strategies, address enrolment and retention issues.
o Review and approval of monitoring trip reports, review data, schedule and conduct CRA meetings/Teleconferences, follow up on outstanding CRFs and DCFs, address site issues found during audits, ensure TMF is updated.
o Coordinate study close-out, case book preparation, reconciles payments, study budget, complete all archiving, and reconcile TMF.
o Line management. May be responsible for overall performance management of direct reports, including: oversee personnel and assure adherence to GCP/ICH and SOPs/WPs, lead the performance review process for direct reports, identify and address performance issues and training needs, provide guidance regarding company policies and procedures.
University Degree Life Sciences
Previous experience in early development (phase I trials)
Solid experience in oncology and hematology
Fluent in English
Experience as a Study Manager minimum 1.5 years in the international environment.
Availability to start October-November.