Sérfræðingur í gagnastjórnun / Senior 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.

Helstu verkefni og ábyrgð:

• Samræma verkefni og aðgerðir við skipulagningu, eftirlit og afhendingu klínískra birgða.
• Hafa umsjón með yfirferð skjala sem tengjast framleiðslu, stöðugleikaprófunum og gæðalosun.
• Umsjón með skjölum sem tengjast frávikum og öðrum upplýsingum sem krefjast óblindrar úthlutunar.
• Skipuleggja og útfæra ferla fyrir pökkun, merkingu, blindun og dreifingu lyfja.
• Skilgreina og samræma ferli fyrir fulla QP-losun.
• Hafa umsjón með skjölum og gagnastjórnun til að tryggja GMP og GCP með tilliti til verkefnamarka og tímalína.
• Skipuleggja yfirferð á rafrænum lotuskrám.
• Hlaða inn gögnum í Veeva Clinical Vault.
• Önnur störf sem tengjast vinnu í gagnastjórnunarhóp.
• Vinna náið með þverfaglegum teymum.

Menntunar- og hæfniskröfur:

• BSc í líffræðilegum vísindum, líftækni eða sambærilegu.
• Reynsla af gagnaöflun, samantekt og greiningu.
• Góð kunnátta í Word og Excel, þekking á GraphPad Prism og JMP er kostur.
• Góð færni til að vinna sjálfstætt og í fjölbreyttum teymum.
• Skipulagshæfni, góð tímastjórnun og sveigjanleiki.

[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.

What we offer:

• An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
• The chance to be a part of a global and fast-growing company.
• An international work culture that encourages diversity, collaboration and inclusion.
• Positive, flexible, and innovative work environment.
• Support for personal growth and internal career development.
• Company social events and milestone celebrations.
• Excellent in-house canteen and coffee house.
• Exercise and wellbeing support for full-time employees.
• On-site shower facility.
• Transportation grant towards eco-friendly modes of travel for full-time employees.
• Internet at home for full-time employees.

Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.