Global Clinical Study Delivery Lead - Multiple Positions Available, Open to flexible working
Would you like to be part of GSK's clinical development team, with an opportunity to drive and lead scientific innovation to deliver the next generation of transformational medicines for patients in areas of high unmet need? If so, this could be an excellent opportunity to explore. We have openings across a wide variety of therapy areas.
As a Study Delivery Lead in Global Clinical Sciences and Delivery (GCSD) you will be responsible for leading the planning, implementation and reporting of clinical studies to time, quality, budget, company standards, scientific, ethical and regulatory requirements.
Your responsibilities will include, but are not limited to:
- Accountable for coordination of a fully feasible Study Protocol, Informed Consent Forms, Study Procedures Manuals and Clinical Study Reports.
- Accountable for the study delivery strategy (e.g. country selection, recruitment of diverse study participants, patient engagement strategy, recruitment plan)
- Drive assessment, selection, engagement, and management of appropriate vendors.
- Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
- Make decisions which balance risk/benefit with clear understanding of impact on the study and project; acts to mitigate risk where appropriate.
- Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project budget allocation.
- Actively partner to build relationships and collaborate with staff in other global functions.
- Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
- Bachelor's degree in life sciences or neuroscience
- 3 to 6 years' experience within the pharmaceutical industry or CRO environment in clinical operations
- Experience of leading study teams
- Experience in study management, global regulatory guidelines and ICH/GCP
- Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports.
- Experience working with investigators, external experts, Contract Research Organizations and vendors
- Excellent influencing and negotiation skills
- Advanced degree in life science or related field (e.g. MS, PhD, PharmD)
- Highly developed communication skills appropriate to the target audience (including senior leaders), promoting effective decision-making where necessary
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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