Sérfræðingur í gagnastjórnun / Scientist - Data Management

Alvotech leitar að vísindamanni í gagnastjórnun til að ganga til liðs við PharmSci Strategy & Execution. Þessi staða felur í sér að skipuleggja, samræma og hafa umsjón með gagnastjórnun sem tengist klínískum birgðum, gæðalosun, gagnavinnslu og skjölum sem uppfylla GMP og GCP staðla.

Við bjóðum upp á skemmtilegt og krefjandi starf í alþjóðlegu umhverfi ásamt fjölbreyttum tækifærum til starfsþróunar. Ef þú hefur áhuga á þessu spennandi tækifæri, hvetjum við þig til að kynna þér það betur á heimasíðu okkar!

Við hvetjum þig einnig til að skoða starfasíðuna okkar: Join us - Alvotech - Better Access Better Lives sem veitir góða innsýn í vinnustaðamenninguna, gildin okkar og það frumkvöðla starf sem við stöndum fyrir.

[English]

Overview of role:

Alvotech is looking for a Senior Scientist in Data Management to join our PharmSci Strategy & Execution department. This role focuses on coordinating, overseeing, and managing data related to clinical supplies, quality release, data processing, and document handling in compliance with GMP and GCP standards.

Key Responsibilities:

• Coordinate tasks and activities for planning, oversight and release of clinical supplies, with the clinical operations team, the Contract Manufacturing Organisation (CMO) and Contract Research Organisation (CRO).
• Act as the key point of contact for review of documents related to clinical supply manufacturing, stability testing and quality release for clinical trials.
• Act as key point of contact for temperature excursions and other information containing unblinded treatment allocation information.
• Prepare and plan detailed process for all steps and tasks for management of Clinical Supplies until delivery to sites or country depots, including but not limited to, packaging, labelling and blinding activities.
• Define process for full QP release.
• Develop Investigational Medicinal Product (IMP) distribution and returns drug plans and manage clinical supply documentation to maintain Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) compliance, in accordance to project scope and timelines.
• Collaborate with cross-functional individuals (e.g. Clinical Operations, Clinical & Medical Quality, Global Regulatory Affairs, Program Management, Pharmaceutical Science Stability testing, TechOps, Quality Assurance and Qualified Persons).
• Review clinical supply packaging and labelling documentation
• Co-ordinate review of electronic Batch Records
• Act as primary Point of Contact internally and externally (CRO and clinical site as needed) for Temperature Excursion notifications.
• Review Temperature Excursion documentation and co-ordinate assessment of Fit-For-Use decision.

Qualifications:

• BSc in a scientific subject, preferably Biotechnology or similar.
• Experience in data gathering, summarizing and evaluation.
• Good working knowledge with Word and Excel, familiarity with GraphPad Prism or JMP is a plus.
• Ability to work independently and cross-functionally with diverse teams.
• Strong organizational, multitasking, and adaptability skills.

We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website.

We encourage you to visit our Career page (link: Join us - Alvotech - Better Access Better Lives) It offers valuable insights into our culture, values, and the innovative work we do.