Biomarker Operations Specialist - Basel

☞ Global Personal Partner

View: 184

Update day: 26-03-2024

Location: Basel Basel-Stadt BS

Category: Executive management Production / Operation

Industry: Staffing Recruiting Health Wellness Fitness Hospital & Health Care

Position: Entry level

Job type: Full-time

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Job content

Einführung

Our profession and our passion "HR Management."

Global Personal is an independent company of the Interiman Group SA with over 100 employees offering a complete range of human resources services at 21 locations in German-speaking Switzerland.

For our client, an international orientated Pharma company, we are looking for a reliable and motivated (m/f/d)

Biomarker Operations Specialist m/w/d 100%

As part of pRED Clinical Operations, the Biosample Operations Specialist drives alignment of study and project level strategies within the overarching therapeutic area strategy for biosamples, through close partnership with the Biosample Therapeutic Area Leaders (BTALs), service providers (including lab vendors) and DTA stakeholders. The BOS is responsible for the delivery and implementation of the biosample strategy within multiple clinical programmes in accordance with the requirements of quality, ethical and regulatory standards including ICH/GCP/GLP. He/she ensures project level consistency for biosampling across studies and is the primary point of contact within Biosample Operations for project, clinical and study teams. He/She delivers expert input on strategic direction and operational considerations for Biomarker sampling to project and study teams; leads or contributes to innovation and continuous improvement activities in the area of biosample collection, processing and data delivery.

Perfect Candidate

AUFGABENBESCHREIBUNG:

The perfect candidate is someone with strong project management experience, someone that has worked within sample management before. We need someone used to interact / manage clinical sites, CROs, sponsor sites or study teams. This position is on a project level rather than a study one. This means the successful candidate will be overseeing multiple studies at a time (which is why the project management experience is important).

We need a scientific understanding (especially in biomarkers), therefore a scientific degree is required. Someone with experience working in labs is advantageous.

As always, soft skills are very important: excellent communications, stakeholder management. Multicultural experience is also very appreciated.

Tasks & Responsibilities
  • To provide operational expertise to ensure the successful implementation of the biosample strategy for a given molecule or clinical programme
  • To ensure the appropriate level of sample quality, defining corrective actions if necessary, and acting as a point of escalation for issues at the study and project levels
  • To implement the biosample sourcing strategy within given projects through partnership with the BTAL and other key stakeholders involved in project and study delivery
  • To be accountable for project level oversight (from feasibility to study close) of laboratories/vendors and associated costs involved in biosampling activities and analyses. Provides input to the laboratory selection process to ensure appropriate vendor selection where applicable
  • Leads cross-functional operations team meetings as required to ensure optimal delivery of project biosampling objectives
  • To actively promote knowledge sharing within Clinical Operations and across studies within a project by partnering with stakeholders.
  • To be accountable for the accurate and timely forecasting and management of individual project and study variable costs related to bio-sampling, in collaboration with key stakeholders
  • To provide regular project/study level biosample status updates to key stakeholders as required.
  • To act as a subject matter expert within the Clinical Operations for specific business related topics or processes
  • To contribute to, and occasionally lead, functional process and system improvements to ensure operational excellence
  • Mentor others as required to maximise their capability and contribution to deliver high quality biosamples
  • Partner with cross functional parties and external vendors to communicate and train on relevant processes which underpin the laboratory operating model
  • To contribute to a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels through role modelling the Roche values of courage, passion and integrity
  • Ensures implementation of the ethical and legal framework for biosampling
Erforderliches Profil
  • Minimum 3 years’ experience in project management
  • Experience in sample management: leading and managing biosample operational activities on a range of logistically complex multi-centre clinical studies
  • Experience interacting and managing important clinical stakeholders (e.g clinical sites, CROs, study teams or sponsor sites)
  • Scientific degree & strong biomarker understanding (someone who worked in labs is advantageous)
Start date:
  • Asap
  • 2 months’ notice period max.
Duration:
  • 1 year
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Deadline: 10-05-2024

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