Clinical Study Manager

OverviewSelect how often (in days) to receive an alert: Create AlertWould you like to join an international team working to improve the future of healthcare?Do you want to enhance the lives of millions of people?Grifols is a global healthcare company that since **** has been working to improve the health and well-being of people around the world.We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.At Grifols, we believe that diversity adds value to our business, our teams, and our culture.We are committed to equal employment opportunities that foster an inclusive environment.POSITION SUMMARY:Provides guidance and oversight to internal and external project team members for the successful management of clinical operation activities in accordance with ICH Good Clinical Practice (GCP) Guidelines, applicable regulatory requirements, company standard operating procedures (SOPs), and study protocols, along with the Program Leader's supervision.ResponsibilitiesContributes to the oversight of integrity of clinical data, obtained from conducted clinical trials, to ensure data meets GCP standards, along with the Program Leader's supervision.Provides support in the preparation of clinical status updates to the PMO and to the Upper ManagementParticipates and contributes to internal and external training for clinical trials (e.g. kick-off meeting, Investigator meeting)Ensures appropriate training is conducted for CRO staff, vendors, investigators, and study site staff on study requirements and internal SOPs (if applicable)Assists in the identification of study team protocol-specific training requirements and creates a trial-specific training plan for the study team.Contributes to the Request for Proposal (RFP) process and participates in vendor selection.Oversees third party vendors performance (e.g., CROs, central laboratories) including on time study completion, budget adherence, and quality deliverables along with the senior management.Review of monitoring reports, approval of clinical plans, regular review of protocol deviations and oversight of the Trial Master File (TMF) status may be included.Assists in evaluation of vendor performance to ensure early mitigation/resolution of potential issues and serves in key role to develop/implement corrective action plans as appropriate.Performs Sponsor Site Visits at selected sites to oversee the site and monitoring performances, communicate with the site and awareness of protocol burdens.Documentation of Sponsor Visits and follow-up of appropriate corrective and preventive actionsLeads meetings with CROs, vendors, and multi-functional teams 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.Reviews escalated issues from study clinical research associates (CRAs) to ensure adequate mitigation plans are implemented (e.g., investigational site monitoring and site audit report findings).MonitoringOversees in-house and vendor monitoring activities including selection of sites, identification of Protocol Deviations and implementation of CAPAs.Drafts, reviews and approves relevant documents including informed consent, site worksheets, pharmacy manual, central laboratory manual and clinical monitoring plan along with the Program Leader's supervision.Clinical Trial Design/PerformanceOversees study centers to ensure timely execution of the clinical studies generating quality data.Offers clinical input/review to clinical documents (e.g., protocols, investigator brochures, pharmacy manual, clinical study reports)Provides clinical input in the development of case report forms, data management plan, and data listings review.Collaborates with Biometry to ensure timely data transfers for data cleaning, review and analysis.Contributes to the review of protocol deviations and data listings to ensure integrity of data and identify trends on ongoing basis, along with the Program Leader.Contributes to the resolution of escalated study conduct issues from study centers, regulatory authorities and IRBs/IECs.Tracks and assists in the development of study specific timelines, including management and mitigation of deliverables.Clinical Trial MaterialRequests, distributes and updates insurance certificates for clinical studies.Partners with Manager of Clinical Trial Material supplies to ensure timely manufacturing, packaging, labeling, and shipping of supplies are created according to regulatory/country specifications in required timeline, along with the Program Leader's supervision.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 serious adverse events (SAEs) that are reported and ensures SAE/SUSAR reporting to IRB/IEC and Principal Investigators, when applicable.Provides assistance in the management of the TMF process, including ongoing maintenance, accurate filing and administration of quality control (QC) plan.Ensures responses to site audits are adequately managed by designated clinical staff.SafetyMaintains awareness of SAEs that are reported and ensures SAE/SUSAR reporting to IRB/IEC and Principal Investigators, when applicable.Trial Master File (TMF)Provides assistance in the management of the TMF process, including ongoing maintenance, accurate filing and administration of QC plan.Ensures responses to site audits are adequately managed by designated clinical staff.Audits/Inspections/Quality Assurance (QA)Contributes responses to vendor/site audits, along with the Program Leader's supervision.Prepares responses to internal audits, along with the Program Leader's supervision.Provides support to preparation of site inspections, attends site inspections, and supports responses to site inspections, as necessaryAssists in the preparation of internal inspections, attends internal inspections, and contributes to responses to internal inspections, along with the Program Leader's supervision.Supervises quality of the clinical trial and ensures implementation of CAPAs to quality deviations and misconducts, along with the Program Leader's supervision.Person SpecificationAdvanced verbal, written and interpersonal skills that enable cross-functional issue resolution.Advanced strategic thinking abilities for proactive planning and decisive decision making.Advanced ability to set and meet deadlines, multitask, and prioritize based on program and/or study needs.Advanced ability to facilitate and/or present at departmental, study, project and investigator meetings.Advanced ability to train and mentor CRAs.Bachelor's degree in relevant disciplineTypically requires 5-8 years of experience in clinical research, including 2 years in a study management/leadership role.Strong leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel.8+ years of experience in clinical research, including 2 to 5 years in a study management/leadership role.Master's degree or higher-level degree in relevant disciplineOur Benefits Include:Highly competitive salaryGroup pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will matchPrivate Medical Insurance for the employee (Irish Life)Ongoing opportunities for career development in a rapidly expanding work environmentSuccession planning and internal promotionsWellness activities- Social activities eg.Padel, Summer EventsWe understand that self-doubt can hold talented individuals back from applying for opportunities.We encourage everyone who meets the qualifications to apply – we're excited to hear from you#J-*****-Ljbffr