Biosample Operations Specialist
- Contract Type
TalentSource Life Sciences is currently searching for an experienced Biosample Operations Specialist to work with one of our partner pharmaceutical companies in the Hertfordshire area.
This is a temporary position with TalentSource for 12 months with the possibility of being extended, on a full time basis. The successful candidate will be working on studies dedicated to one client.
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.
· Provide operational expertise to ensure the successful implementation of the biosample strategy for a given molecule or clinical programme
· Ensure the appropriate level of sample quality, defining corrective actions if necessary and act as a point of escalation for issues at the study and project levels
· Implement the biosample sourcing strategy within given projects with key stakeholders involved in project and study delivery
· 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
· Actively promote knowledge sharing within Clinical Development Expert Resources and across studies within a project by partnering with stakeholders
· 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
· Provide regular project/study level biosample status updates to key stakeholders as required
· Act as subject matter expert within the team for specific business related topics or processes
· Contribute to, and occasionally lead, functional process and systems 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
· Contribute to a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels through role modelling values including courage, passion and integrity
· Ensures implementation of the ethical and legal framework for biosampling
Education / Qualifications:
· Life Science degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area
Experience, Skills & Knowledge:
· Significant experience implementing clinical trials is required
· Must have project management experience within a central lab
· Extensive experience in leading and managing biosample operational activities on a range of logistically complex multicentre clinical studies
· Demonstrated knowledge of ICH-GCP
· Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
· Demonstrated leadership skills
· Proven ability to successfully achieve results within a multi-cultural and geographically diverse matrix environment
· Proven ability to influence effectively and confidently within a matrix environment
· Knowledge of legal and regulatory environment related to human specimen collection, analysis and retention
· Effective communication skills
· Ability to lead and work across a global matrix team and stakeholder environment
· Ability to work independently and manage multiple competing priorities
· Effective strategic agility
· Ability to work with internal and external partners
· Excellent written and spoken English
· Willingness to travel internationally and work cross-culturally
If you have the experience and are interested in discussing the role for this position, please contact Laura Guascone, Laura.Guascone@CROMSOURCE.com.
Why TalentSource Life Sciences/CROMSOURCE?
CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.
Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.
As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.
To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.
Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.
Keywords: Biomarker, Scientific, Laboratory, Lab, R&D, Research and Development, CRO, Contract Research Organisation, Freelance, Outsourced, Temporary, Contract, Biosamples, Biosample, Central Lab, Project Manager, PM, Bio-marker, biomarker, bio marker
Biosimilars, Biosample Operations Manager, Freelance
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