Biological Sample Manager

We are looking to recruit a biological sample manager to Affibody’s clinical operations group. The location is at our newly established premises in Solna.

As biological sample manager you will have an important role in the in clinical operations group, operating on a global reach. You will be mainly directed by the objectives and demands of the clinical trials.

The role in general

As biological sample manager you will be part of integrated clinical trial teams, responsible for the planning, set-up, and management/logistics of all kind of biological samples (blood and tissue), during trial conduct through closure/archiving.
In this role you will be the main contact person for the vendors in charge for the respective activities related to clinical trial samples (e.g. central Lab, clinical CRO, specialty labs), i.e. with respect to designing kits, working out shipment requirement and schedules, samples shipment logistics and contributing to the outsourcing/costing process, etc.)  Furthermore, you will have tight cooperation with the corresponding function in Translational Medicine to ensure integrated planning for required sample analyses for the various needs and purposes on trial and project level including the adequate documentation.

As biological sample manager in the clinical operations group your main responsibilities include:

  • Set-up of sample management plans in close cooperation with according function in Translational Medicine for the lifecycle of clinical trials
  • Keeping oversight of the availability of samples, status of sample analysis and reporting of results throughout the clinical trials until the final clinical trial report is available, and for interim and meta-analysis (on program level), and other purposes
  • Report progress of status of the clinical trial sample collection, reconciliation, transfer to specialty lab(s) and analysis of results to trial teams
  • Continuous alignment with other functions in trial teams
  • Main point of contact for vendors regarding coordination of logistics for sample availability for analysis in clinical trials, from planning stage to trial closure / finalization of concerned reports
  • Involved in outsourcing activities with regards to biological samples (e.g. central labs) in clinical trials in close cooperation with outsourcing & contracts management and internal trial teams, including supervision of performance and timely provision of deliverables (including check of invoices for contracted services)
  • Coordination, development, updating and review of trial specific sample management documents, including laboratory manuals, data transfer agreements, etc.
  • Contribution to clinical trial documents, protocols, CRFs, etc. from the laboratory requirements perspective and from general trial management experience

Qualifications

The right candidate fulfills the following qualifications:

  • A degree in Life Science or similar education
  • At least 5 years of experience in a similar role / clinical trial management at a pharmaceutical or biotech company, or at a CRO
  • Experience from cross functional teamwork in clinical development setting
  • Advanced knowledge in quality and regulatory requirements in the GC(L)P governed arena
  • Excellent understanding of all trial management aspects and interdependences in clinical trials
  • Advanced knowledge of Microsoft applications, especially in tracking tools (e.g. Excel, and project management tools)
  • Excellent verbal and written communication skills in English and ability to communicate in a business environment, proficiency in the Swedish language (oral) is an advantage

Personal attributes

To be successful in the role you need to be highly self-motivated and self-driven with strong communication/interpersonal skills and a pronounced organizational talent with high attention to details. You need to have the ability to collaborate with strong team working skills to establish and maintain good collaboration with different parties, both externally and internally. You have capabilities to coordinate and make long-term plans, monitor the plans and to handle/mitigate deviations as they occur. You provide sound solutions to problems and identify with whom to communicate and interact with. The role requires both operational management and strategic oversight. You have the ability to work independently and to make priorities in order to deliver business critical items in time

Application

We will interview candidates from end of August 2020 and continuously, and welcome your application today!

Please send your application (CV and a note on why you think this is your next step) to hr@affibody.se. Please note that applications will be reviewed and handled from mid-August 2020. If you have any questions about the role, please contact Head of Clinical Operations, Gerda Vlasitz, at gerda.vlasitz@affibody.se.

Affibody in short

Affibody is a Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.

Upcoming reports Financial calendar

  • Interim Report January to March 2020 (May 15, 2020)
  • Interim Report January to June 2020 (August 21, 2020)
  • Interim Report January to September 2020 (November 13, 2020)
  • Year End Report 2020 (February 2021)