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Laboratory Study Asset Manager

2 months ago

Durham, North Carolina, United States GSK LLP Full time

The Laboratory Study Asset Manager within the HBSM Central Team will play a pivotal role in enhancing alignment across sample management strategies within various projects and studies. This position involves significant engagement in initiatives aimed at process enhancement and simplification, utilizing advanced expertise and knowledge. Additionally, the role includes the implementation of effective onboarding for newcomers, as well as providing comprehensive training, coaching, and mentoring for team members.

Key Responsibilities:

  • Act as the Subject Matter Expert for essential processes within the team, as well as for critical processes that connect with other Global Clinical Operations (GCO) and Laboratory Group Departments:
    • Offer high-level expertise in transversal initiatives and projects focused on process improvement and simplification, ensuring effective collaboration between the Human Biological Samples Central Team (HBSM CT) and other GCO Departments (e.g., GMASE, Data Management, Project/Study Delivery teams) and Laboratory Groups (e.g., Precision Medicine, Vaccines CL&AP).
    • Guarantee that standardized processes and operational methodologies are established across all priority projects and studies (for Vaccines and Medicines) for key activities (e.g., LSMs, processes like HBS Custodianship, BFL process, setup of Central Laboratories, Blinding and Reconciliation Strategy).
  • Oversee the delivery of a comprehensive sample management training strategy to all relevant stakeholders across GCO and other laboratory groups, ensuring high-quality execution of HBS management throughout clinical trials.
  • Provide effective coaching and mentoring to Laboratory Study Manager team members, ensuring the quality of the onboarding program for newcomers.
  • Engage with senior management both internally and externally, responsible for influencing, communicating, and driving significant organizational change.
  • For priority projects and studies, ensure effective collaboration between HBSM CT and Clinical Study Teams by contributing to study protocols, laboratory instructions for investigator sites, and addressing sample management or testing issues.
  • Specialize in Therapeutic Areas including Vaccines, Immuno/Respiratory, Infectious Diseases, Hepatology & Emerging Diseases, and Oncology.
  • Contribute to the forecasting of budget and resources.
  • In addition to the Asset LSM role, manage a few complex studies to maintain familiarity with processes and requirements associated with ongoing improvements and training initiatives.
Why You?

Basic Qualifications:

We seek professionals with the following essential skills to help us achieve our objectives:
  • Bachelor's degree in a scientific discipline or equivalent experience.
  • Over 8 years of operational experience in clinical study execution, preferably within clinical laboratory activities.
  • Experience in Project Management beyond one's own area of expertise.
  • Proficiency in integrating complex inter-departmental processes, databases, and systems.
  • Knowledge of laboratory processes and comprehensive understanding of ICH-GCP/GCLP regulations.
Preferred Qualifications:

If you possess the following attributes, it would be advantageous:
  • Master's degree in a scientific discipline or equivalent experience.
  • Strong ability to proactively identify problems and propose solutions, as well as to escalate issues to Management.
  • Effective communication skills (both written and verbal) with the ability to influence key stakeholders at all organizational levels.
  • In-depth understanding of GSK's organizational structure, including key contacts within the R&D clinical organization.
  • Proven experience in clinical project planning, management, and issue resolution.
  • Experience managing a remote matrix network of internal and external stakeholders from diverse cultural and scientific backgrounds.
  • Ability to align various parties to build alliances and influence across national and cultural boundaries.
  • Experience working across cultures and geographies with a strong awareness of cultural differences.
  • Exposure to FDA or other regulatory authority inspections.
Why GSK?

GSK is a global biopharmaceutical company dedicated to uniting science, technology, and talent to advance healthcare. Our mission is to positively impact the health of billions of people while delivering sustainable shareholder returns. We focus on preventing and treating diseases through vaccines and innovative medicines, with a commitment to scientific excellence in key therapeutic areas.

Our success is driven by our people. We strive to create an environment where individuals feel inspired, valued, and included, fostering personal and professional growth. If you share our ambition, we invite you to join us in our journey to make a difference.