Sample Management Lead (SML)
Hr On Demand Sweden AB / Biomedicinjobb / Mölndal
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hela Sverige Heres a chance to join our dynamic team at Ribocure Pharmaceuticals AB as an SML, where you will contribute in Ribocures mission to build a world-leading RNA therapeutics R&D company in Sweden and help patients all over the world. We are dedicated to developing innovative treatments that make a difference in patients' lives. At Ribocure, we foster a culture of excellence and are committed to the highest standards of quality in everything we do.
We are now searching fora highly motivated colleague to join our Clinical Sample Management Team.
About the Job
As ourSample Management Lead you will playa coordinating role in a cross-functional setting. The responsibilities cover the entire life cycle of our clinical samples, from protocol development to sample analysis and destruction, including laboratory vendor selection and contracting.
The career level will be adjusted based on the candidate's experience, allowing for flexibility in responsibilities and expectations
Key Responsibilities of the Position1. Laboratory Vendor Selection and Contract Management Lead the identification, selection, and contracting of appropriate laboratories for Pharmacokinetic- (PK), Pharmacodynamic- (PD) and Anti-Drug Antibodies (ADA) analysis.
Collaborate closely with the Clinical Operations Trial Lead and cross-functional experts from various departments like Bioanalysis, Pharmacology, Medical, Translational Science and Clinical Pharmacology to ensure that selected laboratories and assays meet scientific and regulatory requirements.
2. Contribute to Clinical Trial Protocol development and support Regulatory and Ethical Committee submissions Ensure sample collection time points are cost efficient and patient/site centric in regards of blood volumes collected and operational aspects from a site perspective.
Review of trial participant information and the Informed Consent Form.
Responsible for Biobank applications, when applicable.
3. Clinical Sample Management and Lab Kit Supply Coordination Ensure accurate lab kit development and site supply, as well as lab manual development/review.
Training of site staff and CRAs at Site Initiation Visits and continuous support throughout the trial.
Responsible for clinical trial-level sample management, ensuring that samples are delivered from the right patients to the laboratory at the right time.
Ensure Data Transfer Agreements are in place.
4. Data Tracking Oversight and Issue Resolution Coordination Work closely with Clinical Operations, Clinical Pharmacology/Modeling, Medical and selected vendors to ensure critical data is available, analyzed and transferred in a timely manner.
First point of contact and coordinating troubleshooting of PK, ADA and PD sample analysis and assay issues, and proactively anticipating and mitigating potential problems.
5. Communication and Process Improvement Proactively communicate updates and timelines to stakeholders, provide advice and guidance on the sample management process
Collaborate with preferred vendors and quality assurance personnel to develop improvements in the sample management process.
6. Biobank Support the Ribocure Biobank manager in biobank related activities, such as handling of clinical samples, drafting Material Transfer Agreements and assisting in the annual quality control.
Essential Requirements
You must live in the proximity of Gothenburg, Sweden, to be qualified for this position.
University degree, preferably in pharmaceutical sciences, pharmacology, biomedical engineering, biochemistry, biological science, or discipline associated with medicine or clinical research
Minimum of 3 years' experience in the pharmaceutical or biotech industry
Hands on experience and/or technical knowledge related to different methods and assays used for analyzing PK, ADA, PD and biomarkers (particularly different ELISA techniques, MSD and LC-MS)
Strong competence in English communication, both in writing and speaking
Ability to work independently as well as in a cross-functional setting
Proven ability to coordinate effectively and manage multiple tasks simultaneously in a fast-paced and dynamic work environment
Desirable Requirements Experience of working in a global context where you appreciate and understandcultural differences
Experience in clinical development, working with clinical trials and central lab activities as a sponsor, CRO, or at the site level
Experience of setting up bioanalytical and/or PD assays and related trouble shooting
Experience in biobanking, including handling regulatory requirements, compliance, and operational processes
Our offerWe offer a competitive salary, comprehensive benefits package, and opportunities for growth and advancement. The career level will be adjusted based on the candidate's experience, allowing for flexibility in responsibilities and expectations. We are an equal opportunity employer and welcome applicants from all backgrounds.
We invite you to joinour fast-expanding global organization towards being one of the leading players in oligonucleotide therapeutics.
If you believe this job would be a good match for you, apply as soon as possible but no later than December 15th, 2024.Kindly note that we will assess candidates on a continuous basis.
You apply easily here using the Send Application button where youwill be able to upload CV and cover letter in the system.
Welcome!
Ersättning Lön enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2024-12-15
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Hr On Demand Sweden AB (org.nr 556743-5036)
Arbetsplats HR On Demand
Kontakt Karin Johansson
karin.johansson@ribocure.com +46736372601 Jobbnummer 9021829
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