Head, Specimen Management - Oncology
- Waltham, MA
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence
Posted Date: Apr 8 2020
The Oncology Experimental Medicine Unit (EMU) is seeking a Head, Clinical Trial Specimen Management. This individual will be responsible for expanding the existing Oncology clinical trial specimen management department to meet growing business needs. Remits of the department include sample management planning, contributing to relevant clinical trial documents, and managing clinical trial specimens over their entire study lifecycle of collection, testing, and disposition.
- Scope of responsibilities will include optimizing processes, expanding and managing the specimen management team, developing and communicating strategy and implementation plans, audit readiness, and ensuring overall operational excellence.
- Build and manage a team of clinical trial specimen management professionals
- Develop and implement Oncology clinical trial specimen management strategy
- Develop and implement activity specific SOPs, GUIs, other controlled documents
- Ensure Specimen Management department's activities are aligned with program and study objectives
- Accountable for audit readiness, response to audit findings
- Operate in a matrix environment including clinical development, EMU Tissue Bank, Quality
- Responsible for change management activities for Oncology clinical trial specimen management
- Other responsibilities as assigned
We are looking for professionals with these required skills to achieve our goals:
- 5+ years of clinical trial specimen management experience
- BS in a STEM related field or BSN
- 5+ of Laboratory experience
- 5+ of Oncology experience
- Ability to work in a fast-paced and dynamic corporate environment with changing priorities, and flexibility to support multiple programs simultaneously.
- Ability to attract, develop and retain talent is an essential component of this position.
- Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of confidentiality.
- Ability to problem solve using innovative thinking and good decision making.
- Ability to lead innovation, change and drive for results.
- LIMS experience - familiarity with specialized data for sample management
- Experience with CLIA laboratory testing
- Knowledge of UK Human Tissue Act, EU GDPR
- Preferred Qualifications
- If you have the following characteristics, it would be a plus:
- PhD or advanced degree in a medical field
- Direct Clinical Trial Development team experience preferred
Our values and expectations are at the heart of everything we do and form an important part of our culture.
As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate the Following Capabilities
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
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