Asset Laboratory Study Manager

Site Name: Mississauga Milverton Drive

Posted Date: Oct 15 2024

Job Purpose:

The Asset Laboratory Study Manager within HBSM Central Team will ensure increased and strengthened alignment across sample management strategies within projects & studies, prominent involvement in process improvement / simplification projects and initiatives (internal within HBSM CT, but also across Global Clinical Operations) by using high-level expertise and advanced know-how, as well as rolling out adequate newcomers onboarding, transversal training, coaching, and mentoring of group members.

Key Responsibilities :

• Be responsible as Subject Matter Expert for key/critical processes of the team, as well as transversal key processes that link into other Global Clinical Operations (GCO) and Laboratory Group Departments:
• Providing high-level expertise input in transversal initiatives/projects regarding process improvement/simplification and ensuring effective transversal interface between Human Biological Samples Central Team (HBSM CT) and other Global Clinical Operations Departments (e.g., GMASE, Data Management, Project/Study Delivery teams, …) and Laboratory Groups (e.g. Precision Medicine, Vaccines CL&AP…)
• Ensure standard processes and ways of working are in place across all priority projects and priority studies (for Vaccines and Medicines) for all key activities (e.g., for LSMs, processes like HBS Custodianship, BFL process, set-up of Central Laboratories, Blinding and Reconciliation Strategy…)
• Ensuring delivery of sample management training strategy to all relevant stakeholders across GCO and other laboratory groups to ensure high quality delivery of HBS-management throughout the clinical trials.
• Ensuring adequate coaching and mentoring of LOSM team members (e.g., Laboratory Study Managers), as well as ensuring quality delivery of onboarding program of newcomers
• Interacts with senior management both internally and externally to the company and is responsible for influencing, communicating, and driving a significant amount of change at all levels of the organization.
• For priority projects/studies ensure effective interface between HBSM CT and Clinical Study Teams, by providing input in study protocol, laboratory instructions for investigator sites, informing about testing due dates, sample management or testing issues.
• Specialize in Therapeutic Areas (Vaccines, Immuno/Respiratory, Infectious Diseases, Hepatology & Emerging Diseases, Oncology)
• Provide input in forecasting of budget & resources.
• Asset LSM role might still be expected to cover a few complex studies in the LSM role, to ensure that they are familiar with processes and requirements, associated with ongoing processes improvements, training initiatives.
  
  

Education Requirements :

• Master’s degree in sciences or equivalent background
• Demonstrated expertise in Project Management beyond his/her own field of expertise.
• Demonstrated capability to integrate complex inter-departmental links, processes, databases, and systems.
• Demonstrated generalist knowledge and competency in laboratory processes and extended knowledge of ICH-GCP/GCLP rules.
• Demonstrated fluency in spoken and written English beyond scientific English, knowledge of French is an asset.
• Good helicopter view especially to proactively detect problems and define possible solution and/or to surface issues to Management.
  
  
  

Job Related Experience :

• At least 8-10 years of operational experience in clinical study conduct, preferably in clinical laboratory activities.
• Ability to effectively communicate (written and verbal) and influence key stakeholders at all levels of the organization both internally and externally.
• Deep understanding of GSK organizational structure including key contacts in R&D clinical organization, Lines/Functions
• Proven experience in clinical project planning, project management and issues resolution
• Experience of managing business remote matrix network of internal and external stakeholders of multicultural and multidisciplinary people with different expertise and various scientific background
• Ability to align of all the parties involved to build alliances and influence across national and cultural boundaries (up to 20 in different countries, including Africa and Chin
• Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.
• FDA or other competent authority inspection exposure
  
  
  

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected]. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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