Serfringur i gagnastjornun / Senior Scientist - Data Management - Reykjavik (Iceland)
- Alvotech
- Virginia
- Full Time
Serfringur i gagnastjornun / Senior Scientist - Data Management
Reykjavik (Iceland) - Full time
Deadline: June 21, 2025
Alvotech leitar a visindamanni i gagnastjornun til a ganga til lis vi PharmSci Strategy & Execution. essi staa felur i ser a skipuleggja, samrma og hafa umsjon me gagnastjornun sem tengist kliniskum birgum, galosun, gagnavinnslu og skjolum sem uppfylla GMP og GCP stala.
Helstu verkefni og abyrg:
Samrma verkefni og agerir vi skipulagningu, eftirlit og afhendingu kliniskra birga.
Hafa umsjon me yfirfer skjala sem tengjast framleislu, stougleikaprofunum og galosun.
Umsjon me skjolum sem tengjast fravikum og orum upplysingum sem krefjast oblindrar uthlutunar.
Skipuleggja og utfra ferla fyrir pokkun, merkingu, blindun og dreifingu lyfja.
Skilgreina og samrma ferli fyrir fulla QP-losun.
Hafa umsjon me skjolum og gagnastjornun til a tryggja GMP og GCP me tilliti til verkefnamarka og timalina.
Skipuleggja yfirfer a rafrnum lotuskram.
Hlaa inn gognum i Veeva Clinical Vault.
Onnur storf sem tengjast vinnu i gagnastjornunarhop.
Vinna nai me verfaglegum teymum.
Menntunar- og hfniskrofur:
BSc i liffrilegum visindum, liftkni ea sambrilegu.
Reynsla af gagnaoflun, samantekt og greiningu.
Go kunnatta i Word og Excel, ekking a GraphPad Prism og JMP er kostur.
Go frni til a vinna sjalfsttt og i fjolbreyttum teymum.
Skipulagshfni, go timastjornun 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 agileenvironment.
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.
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Reykjavik (Iceland) - Full time
Deadline: June 21, 2025
Alvotech leitar a visindamanni i gagnastjornun til a ganga til lis vi PharmSci Strategy & Execution. essi staa felur i ser a skipuleggja, samrma og hafa umsjon me gagnastjornun sem tengist kliniskum birgum, galosun, gagnavinnslu og skjolum sem uppfylla GMP og GCP stala.
Helstu verkefni og abyrg:
Samrma verkefni og agerir vi skipulagningu, eftirlit og afhendingu kliniskra birga.
Hafa umsjon me yfirfer skjala sem tengjast framleislu, stougleikaprofunum og galosun.
Umsjon me skjolum sem tengjast fravikum og orum upplysingum sem krefjast oblindrar uthlutunar.
Skipuleggja og utfra ferla fyrir pokkun, merkingu, blindun og dreifingu lyfja.
Skilgreina og samrma ferli fyrir fulla QP-losun.
Hafa umsjon me skjolum og gagnastjornun til a tryggja GMP og GCP me tilliti til verkefnamarka og timalina.
Skipuleggja yfirfer a rafrnum lotuskram.
Hlaa inn gognum i Veeva Clinical Vault.
Onnur storf sem tengjast vinnu i gagnastjornunarhop.
Vinna nai me verfaglegum teymum.
Menntunar- og hfniskrofur:
BSc i liffrilegum visindum, liftkni ea sambrilegu.
Reynsla af gagnaoflun, samantekt og greiningu.
Go kunnatta i Word og Excel, ekking a GraphPad Prism og JMP er kostur.
Go frni til a vinna sjalfsttt og i fjolbreyttum teymum.
Skipulagshfni, go timastjornun 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 agileenvironment.
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.
Powered by
50skills
By using the site, you agree to our cookie policy.
DISMISS
Job ID: 480396429
Originally Posted on: 6/8/2025
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