Project Manager – Clinical Trial Logistics, Import/Export

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November 21

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Oximio

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Pharmaceuticals • Biotechnology • B2B

Oximio is a global clinical-trial logistics and supply-chain company that provides tailored cold-chain transport, storage, customs and depot services, sourcing of comparators and ancillary supplies, and patient-focused trial support (direct-to-patient, home nursing, transportation/reimbursement). The firm operates an international network of bonded depots and partners, offers specialized handling for biosamples and cell & gene therapies across temperature regimes down to -196°C, and supports CROs, CDMOs and sponsors with project management, labelling, QP release and regulatory/import services.

201 - 500 employees

Founded 2004

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

📋 Description

• Coordinate and complete all projects on time, within budget and to the client requirements • Oversee all aspects of projects, monitoring and summarising progress • Ensure reports are prepared key stakeholders regarding status of project • Ensure client project is delivered within scope, meets and exceeds client expectations • Coordinate with other departments for implementing global project management strategy • Carry out project management activity aligned to global Project Management/Clinical Trials strategy • Ascertain and meet customer needs through clinical trials • Ensure all required documentation from a legal perspective is obtained • Drive projects to completion • Accountable for offering bespoke and expert solutions on clinical trials globally • Coordinate internal resources and depots for flawless project execution • Ensure each Clinical Trial has relevant study start-up documents as per SF18, SOPGL30 • Contribute to country requirements database • Ensure each Clinical Trial aligns with contract and international quality standards as well as regional and international legislative requirements • Ensure projects are delivered on-time, within scope and budget • Ensure compliance is aligned within to the Quality policy and standards • Ensure client data handled per local regulatory requirements • Assist in definition of project scope and objective, involving all relevant stakeholders • Manage changes to project scope, schedule, and costs • Measure project performance using appropriate tools • Ensure communication with Depot representatives are updated in inventory system • Manage relationships with clients and stakeholders • Perform risk management to minimize project risks • Liaise with client to clarify specific project requirements • Meet budgetary requirements of projects • Develop comprehensive project plans to be shared with clients • Report on periodic metrics that highlight trends and assess performance against KPI and project Service Level Agreements • Ensure all information is accurately recorded and kept up to date • Investigate non-compliance or incidents within the projects • Ensure business represents best possible image to clients and the public • Ensure compliance with local regulations regarding supply of medical products

🎯 Requirements

• Knowledge of GxP and ISO standards • Experience in Project Management • Expert knowledge of Import/export procedures • Foreign trade standards • Incoterms knowledge • Relevant, demonstratable experience in a similar role • Knowledge and experience in global, multi-site, multi-cultural organisation • National and international import and export regulation awareness • Good knowledge of Microsoft Excel and Word applications • Exceptionally organised and able to schedule and drive work across multiple projects • Good influencing and negotiations skills • Strong numeracy and cost management skills • Has self-awareness and cares about the impact they may have on others • Strategic thinker and good commercial acumen • Fluent in English language written and verbal • Ideally multi-lingual • Engage and build credibility with internally influential individuals • Exceptional attention to detail that delivers quality information • Excellent, caring and honest communication skills that influences all levels of colleagues • Pharmaceutical and medical produce and devices • Ability to deliver on commitments

🏖️ Benefits

• Health insurance • Paid time off • Flexible work arrangements