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:

Manages and Oversees the global Clinical Trial Material (CTM) supply strategy for Grifols clinical studies to ensure quality products are in the right place at the right time to meet evolving clinical study needs. Oversees and coordinates a multitude of CTM program and project management activities throughout the clinical trial lifecycle including forecasting/planning; cGMP clinical packaging/ labelling/distribution; implementation/oversight of IVRS/IWRS systems; management/tracking of global drug shipments; and Investigational Medicinal Product (IMP) accountability/ disposition. Collaborates with both internal and external regulatory, manufacturing, quality and clinical teams to ensure a smooth, responsive and compliant operation. Maintains excellent control over the details and deadlines of a wide range of clinical trial material projects in a dynamic setting.

KEY RESPONSIBILITIES

• Oversees/Develops the short-term and long-range forecasting of clinical study drug, placebo and ancillary supply needs for various protocol designs. Interfaces with internal and external stakeholders to ensure on-time manufacture and delivery of Grifols products.

• Oversees, Develops and executes trial-specific supply strategies. Collaborates with the global Clinical Trial Materials and Finance teams in the development of trial-specific supply strategies. Participates in protocol reviews and advises on CTM topics.

• Accountable for development of global clinical labelling; quality oversight of cGMP/GCP packaging/labelling batch records; identification and procurement of global ancillary supplies; and development of distribution protocols.

• Provides oversight/ensures the development of specifications for IVRS/IWRS systems for randomization and drug supply management.

• Provides oversight/ensures the development and maintenance of pharmacy manuals and investigator site training presentations throughout the trial life cycle.

• Manages and maintains appropriate levels of CTM study drug/supplies for assigned trials to ensure continuous uninterrupted supply to meet evolving study needs while adhering to standards of quality and compliance, as well as budget and timelines. Interfaces with regulatory and clinical teams on import/export requirements and initial drug shipment release approvals.

• Initiates and tracks CTM shipments, shipment receipts, depot inventories, site inventories, IVRS-IWRS functionality, expiry dates, packaging randomization codes and drug accountability.

• Provides guidance/ Monitors CTM shipping/cold-chain distribution activities, identifying issues/variances, and recommending solutions.

• Oversees/Monitors expiration dates and initiates action when expiration date updating is required.

• Provides clear, accurate and timely CTM information flow/ status updates / budget updates to team members and management. Performs on-going risk assessments and contingency planning. Adjusts CTM strategies as required to meet evolving trial needs.

• Functions as an unblinded clinical contact for product technical complaint and temperature excursion and issue resolution.

• Reviews vendor invoices for accuracy and adherence to budget. Provides on-going CTM budget oversight for assigned studies.

• Provides Oversight/ Performs study drug reconciliation activities.

• Ensures CTM files maintained in the Trial Master File per GCP.

• Maintain strong partnerships with a variety of both internal and external teams including: Regulatory, Quality, R&D, Project Management, Finance, Manufacturing, Packaging/Labelling, Supply Chain, CTM vendors, IWRS vendors, investigator site staff (investigators, study coordinators) and CRO staff (CRAs, project management).

PERSON SPECIFICATION

Essential / Desirable Knowledge & Skills

• 3-5 years direct experience in clinical supplies.

• Experience with global Clinical Trial Materials Management or Clinical Supplies with a Sponsor Drug/ Biotech/ Pharmacy Company, Knowledge of cGMPs, and other relevant clinical trial processes and regulations

• Experience with global clinical supplies management and IVRS/IWRS systems, understand global regulations requirement (preference for experience working in clinical supplies management at a sponsor biotech/pharma company)

• CTM previous experience in biologic/pharmaceutical development/ manufacturing operations and/or CRO

• Ability to maintain organizational control over the details and deadlines of a wide range of projects in a dynamic environment.

• Strong analytical, process, problem-solving, working in a fast pace environment, budget forecasting and MS Excel skills.

• Effective communication and collaboration skills.

Qualifications

• Level 3: Bachelor’s degree in a logistics, business, pharmacy or related scientific field and 8+ years global clinical supplies management with a Sponsor company or equivalent combination of education and experience.

Our Benefits Include:

• Highly competitive salary

• Group pension scheme - Contribution rates are 5% employer and 5% employee

• 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

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

Learn more about Grifols (http://www.grifols.com/es/web/international/home)

Req ID: 518788

Type: Regular Full-Time

Job Category: Research & Development