Asset Laboratory Study Manager

2 months ago

Mississauga, Canada GSK Full time

**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 vacc

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