Biosample Operation Specialist
An excellent multinational healthcare company is seeking a skilled Biosample Operation Specialist, to be based in their office in the desirable area of Basel. The organisation is known internationally for their work in pharmaceuticals and diagnostics and their focus on scientific advancement. This is a chance to join a top healthcare organisation who provide an innovative range of diagnostic solutions and medicines. This is a contract role, running for 12 months.
- Driving study alignment 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
- Delivering and implementating of the biosample strategy within multiple clinical programmes in accordance with the requirements of quality, ethical, and regulatory standards including ICH/GCP/GLP.
- Ensuring project level consistency for biosampling across studies and are the primary point of contact within Biosample Operations for project, clinical and study teams
- Delivering expert input on strategic direction and operational considerations for Biomarker sampling to project and study teams.
- Leading or contributing to innovation and continuous improvement activities in the area of biosample collection, processing, and data delivery.
- Providing operational expertise to ensure the successful implementation of the biosample strategy for a given molecule or clinical programme.
- Ensuring the appropriate level of sample quality by defining corrective actions if necessary, and acting as a point of escalation for issues at the study and project levels.
- Implementing the biosample sourcing strategy within given projects through partnership with the BTAL and other key stakeholders involved in project and study delivery.
- Taking accountability for project level oversight (from feasibility to study close-out) of laboratories/vendors and associated costs involved in biosampling activities and analyses.
- Providing input to the laboratory selection process to ensure appropriate vendor selection where applicable.
- Actively promoting knowledge sharing within Clinical Operations and across studies within a project by partnering with stakeholders.
- Being accountable for the accurate and timely forecasting and management of individual projects and study variable costs related to bio-sampling, in collaboration with key stakeholders.
- Acting as a subject matter expert within the Clinical Operations for specific business related topics or processes.
- Mentoring others as required to maximise their capability and contribution to deliver high quality biosamples.
- Partnering with cross functional parties and external vendors to communicate and train on relevant processes which underpin the laboratory operating model.
Skills and Requirements:
- A degree in life sciences.
- Previous experience in Pharma or a CRO in handling the operational needs for biosample management in either/both early and late stage projects and studies.
- Significant experience implementing clinical trials is required.
- Extensive experience in leading and managing biosample operational activities on a range of logistically complex multi-centre clinical studies is preferred.
- Demonstrated knowledge of ICH GCP, clinical, or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Anna Bigiotti at +44 2038542470 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.