Clinical Trial Manager

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 International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, applicable regulatory requirements, company standard operating procedures (SOPs), and study protocols, along with the Program Leader's supervision.

What you will be doing?

• Contributes 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.
  Project Management Office (PMO)/pCTSR:
• Provides support in the preparation of clinical status updates to the Project Management Office (PMO) and to the Upper Management.
  Management/Training Team:
• Participates and contributes to internal and external training for clinical trials (e.g. kick-off meeting, Investigator meeting)
• Insures appropriate training is conducted for clinical research organization (CRO) staff, vendors, investigators, and study site staff on study requirements and internal SOPs (if applicable)
• Assist in the identification of study team protocol-specific training requirements and creates a trial-specific training plan for the study team.
• Vendor Management:
• 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. In particular it may include the review of monitoring reports, approval of clinical plans, regular review of protocol deviations and the oversight of the Trial Master File (TMF) status.
• 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 the monitoring performances, to increase the communication with the site and awareness of protocol burdens.
• Documentation of the Sponsor Visits and follow-up of appropriate corrective and preventive actions
• 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.
• 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).
• Monitoring: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 along with the Program Leader's supervision.
• Clinical Trial Design/Performance:
• Oversees study centers to ensure timely execution of the clinical studies generating quality data.
• Offers his/her 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 institutional review boards (IRBs)/independent ethics committees (IECs).
• Tracks and assists in the development of study specific timelines, including management and mitigation of deliverables.
• Clinical Trial Material:
• Requests, 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 serios adverse events (SAEs) that are reported and ensures SAE/ Suspected Unexpected Serious Adverse Reaction (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.
• Safety:
• Maintains 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 necessary
• Assists 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.

Qualification

• Advanced 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 discipline
• Typically 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 discipline

Our Benefits Include:

• Highly competitive salary
• Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
• Private Medical Insurance for the employee
• Ongoing opportunities for career development in a rapidly expanding work environment
• Succession planning and internal promotions
• Education allowance
• Wellness activities - Social activities eg. Padel, Summer Events

We 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

#LI-FD1

Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3

Learn more about Grifols