Would 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 1909 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:

Oversees the clinical feasibility assessment and strategic planning of clinical trial programs or studies. Executes on these global programs or studies in one or more assigned therapeutic area(s) from decision to start a clinical development up to the market authorization. Manages budgets, timelines and quality of deliverables for assigned program(s) and study(ies) 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.

KEY RESPONSIBILITIES:

• Oversees integrity of clinical data to ensure data meets GCP standards.
• Maintains good knowledge of the literature for the indication being studied and reviews and summarizes all published literature for the therapeutic area of interest.
• Participates in cross functional project teams and presents program information to internal and external audiences.
Investigator Sponsored Research Proposals:
• Provides clinical review/input to Investigator Sponsored Research proposals.
Clinical Development Strategy/Input:
• Assesses best strategic path forward for a clinical program and drives clinical strategy recommendations including timelines and cost to key stakeholders.
• Orchestrates expert meetings to elucidate the best clinical path forward for a clinical program.
• Identifies risks, mitigations, opportunities and contingency plans for assigned program(s) and study(ies).
• Escalates significant issues on program(s) and study(ies) to senior management in a timely manner.
Project Management Office /pCTSR:
• Drafts clinical components from decision to start a clinical development and up to the market authorization (DP1-DP5) gates, liaise cross-functionally to provide clinical input on all development stages and Target Product Profile, as necessary.
• Provides clinical status updates to the Project Management Office (PMO) and to the Upper Management.
Team Management/Trainings:
• Manages direct reports through performance evaluations and addressing professional development.
• Ensures compliance of each Clinical Development trial team with the trial-specific training requirements
• Participates and contributes to internal and external training for clinical program (e.g. Kick-off meeting, Investigator's meeting)
Vendor Management:
• Manages clinical timelines, budgets, and resources against the approved clinical development plan (CDP) in collaboration with contract manager.
• Participates in development of vendor specifications to ensure accurate interpretation of the protocol requirements (e.g. processes and data collection) and contributes to the vendor selection.
• Supports the Program Manager in overseeing third party vendors performance (e.g., contract research organizations (CROs), central labs) including on time study completion, budget adherence, and quality deliverables. In particular it may include the review of monitoring reports, approval of clinical plans, regular review of protocol deviations and activities related to the oversight of the trial master file (TMF) status, completed together with other clinical operations team members.
• Contributes to the evaluation of the vendor performance to ensure early mitigation/resolution of potential issues and develops/implements corrective action plans as appropriate, along with the Program Manager
• 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.
Clinical Trial Design/Performance:
• Provides clinical review/input to clinical documents (e.g., protocols, investigator brochures, periodic safety reports and clinical study reports) and ensures the accuracy and integrity of clinical data prior to submission to regulatory authorities (e.g. Investigational New Drug (IND) application, Clinical Trial Application (CTA), Biologics License Application (BLA), Marketing Authorisation Application (MAA))
• Drafts or provides review/input for publications from clinical study data and white paper literature reviews on new products or safety questions.
• Participates in regulatory authority meetings.
• Partners with Biometry to develop the case report form, data management plan and statistical management plan.
• Reviews protocol deviations and data listings to ensure integrity of data and identify trends on ongoing basis.
• Provides oversight and collaboration with Biometry to ensure timely data transfers for data cleaning, review and analysis.
• Offers guidance to resolve escalated study conduct issues and provides clinical responses to questions from study center personnel, regulatory authorities and institutional review boards/ethics committees.
Audits/Inspections/Quality Assurance (QA):
• Oversees responses to vendor/site audits, as necessary.
• Oversees responses to internal audits.
• Contributes to processes improvement.
• Contributes to preparation of site inspections, attends site inspections, and supports responses to site inspections, as necessary
• Manages preparation of internal inspections, attends internal inspections, and manages responses to internal inspections.
• Supervises quality of the clinical trial and ensures implementation of Corrective and Preventive Actions to quality deviations and misconducts.

PERSON SPECIFICATION:

• 10+ years of experience in clinical research, including 2 to 5 years in a study management/leadership role. 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.
• Strong leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel. Bachelor's degree in relevant discipline
• Typically requires a minimum of 10 years of clinical research experience with at least 6 years clinical trials management / leadership role, including clinical document production, trial execution and involvement in clinical trial feasibility and strategy.
• Master’s degree or higher-level degree in relevant discipline. (2-years’ experience equivalence for a MD and 4-years’ experience for a master’s degree).
• Advanced leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel.

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.

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

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Associate Director Clinical Operations

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