I am recruiting for two Senior Manager Clinical Trial Drug Supply for a multinational pharmaceutical and chemical manufacturer, they are the European leader and one of the largest globally in their field.
Provides guidance and oversight to internal and external project team members for the successful management of all aspects of study operation management in accordance with GCP/ICH Guidelines, applicable regulatory requirements, company SOPs, and study protocols. Participates in the management of budgets and timelines, as well as the preparation of clinical status reports, along with the Program Leader's Supervision
Location: Dublin, Ireland.
Primary Responsibilities for role:
- Ensures integrity of clinical data to meet GCP standards, including identification of trends reported from vendors.
- Participates in the preparation of clinical status updates to the Project Management Office and to the Upper Management, along with the Program Leader
- Manages direct reports including performance evaluations and professional development
- Manages and contributes to internal and external training for clinical trials (e.g. kick-off meeting, Investigator meeting)
- Oversees that study information is effectively communicated to data management, safety, regulatory personnel, and other functional or departmental groups.
- Ensures appropriate training is conducted for CRO staff, vendors, investigators, and study site staff on study requirements and internal SOPs (if applicable)
- Identifies study team protocol-specific training requirements and creates a trial-specific training plan for the study team. Ensures compliance of with trial-specific requirements, along with the Program Leader.
- Works closely with Manager of Contracts in developing and contributing to the study budget, RFPs and Investigator budget template, including participation in and driving the vendor selection process.
- Oversees third party vendors performance (e.g., contract research organizations (CROs), central labs) including on time study completion, budget adherence, and quality deliverables
- Supervises vendor performance to ensure early mitigation/resolution of potential issues and develops/implements corrective action plans as appropriate.
- Manages and leads meetings with CROs, vendors, and multi-functional teams on a day-to-day basis to ensure quality, on budget and timeliness of deliverables.
- Reviews site and vendor invoices to ensure that project expenses are in accordance with work conducted.
- Oversees escalated issues from CRAs to ensure adequate mitigation plans are implemented (e.g., investigational site monitoring and site audit report findings).
- Provides Program Leader with support for managing clinical timelines and budgets
- Oversees in-house and vendor monitoring activities including selection of sites, identification of Protocol Deviations and implementation of Corrective and Preventive Actions (CAPAs)
- Drafts, reviews and approves relevant documents including (but not limited to) informed consent, site worksheets, pharmacy manual, central laboratory manual and clinical monitoring plan.
- Oversees study centers to ensure timely execution of the clinical studies generating quality data.
- Provides clinical input/review to clinical documents for submission to regulatory authorities (e.g., protocols, investigator brochures, clinical study reports).
- Partners with Biometry to develop robust case report forms, data management plan, data transfer plans, data cleaning, data reconciliation and coordinate clinical review of listing
- Reviews protocol deviations and data listings to ensure integrity of data and identify trends on ongoing basis.
- Maintains overall responsibility for ensuring the resolution of escalated study conduct issues from study centers, regulatory authorities and IRBs/ECs.
- Contributes to the identification of risks and opportunities (including contingency and mitigation plans) for the clinical risks and opportunities registry.
- Tracks and develops study specific timelines, manages/mitigates with program timelines
- Requests, distributes and updates insurance certificates for clinical studies
- Partners with Manager of Clinical Trial Material supplies to ensure timely manufacturing, packaging, labelling, and shipping of supplies are created according to regulatory/country specifications in required timeline.
- Monitors adherence to the regulatory/essential document collection process and release of clinical supplies.
- Provides support in clinical product technical complaints and product recall as necessary
- Maintains awareness of SAEs that are reported.
- Supervises the trial master file process including ongoing maintenance, accurate filing and administration of QC plan.
- Ensures responses to site audits are adequately managed by designated clinical staff.
- Contributes responses to vendor/site audits.
- Prepares responses to internal audits.
- Provides support to preparation of site inspections, attends site inspections, and supports responses to site inspections, as necessary
- Participates in the preparation of internal inspections, attends internal inspections, and contributes to responses to internal inspections.
- Supervises quality of the clinical trial and ensures implementation of Corrective and Preventive Actions to quality deviations and misconducts.
Your knowledge and experience:
- Typically requires 12 years' experience in clinical research with at least 8 years clinical trials management / leadership role preferably in a pharmaceutical company.
- Advanced leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel. (If Master's degree or PhD in biomedical science, equivalency is 2-4 years of pharmaceutical industry experience in clinical research).
- Good strategic thinking skills that enables proactive planning. Good verbal, written, and interpersonal skills. Good motivational, decisive decision-making and issue resolution skills. Good ability to prioritize and effectively manage changing priorities.
If you are interested in this Snr Manager Clinical Trial Drug Supply position please contact me to arrange a confidential follow up call: 01 645 5222, Mobile: 087 621 4254, [email protected]