Associate Director, Clinical Trial Management/Local Delivery Lead
GSKAbout the role
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
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Our approach to R&D
This is a remote home-based role for applicants eligible to work in the United States.
Position Summary
Would you like to be part of GSK’s emerging clinical leadership, with an opportunity to accelerate clinical operations on a national scale? If so, this could be an excellent opportunity to explore.
The Associate Director, Clinical Trial Management/Local Delivery Lead provides end‑to‑end leadership for US clinical study delivery, serving as the primary operational link between global study teams and local US operations. It is accountable for achieving recruitment (including patient representation), timelines, budget, quality, and regulatory compliance while leading a highly matrixed, cross‑functional team of internal stakeholders, vendors, and investigative sites. The role drives proactive risk management, continuous improvement, and high‑quality decision‑making while acting as a trusted leader, coach, and GCP subject‑matter expert.
Key Responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.
- Leads the local study team consisting of US clinical operations team members, cross functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery, providing both matrix leadership and project management of study activities within the United States.
- Continuously develops knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site and project management skills and capabilities. Serves as an expert in ICH GCP and GSK written standards.
- Acts as a leader, role model, coach and mentor for the department. Takes a leadership role in standardizing processes, identifying and sharing best practices in support of continuous improvement.
- Represents local/regional clinical operations on global and cross functional initiatives. May serve in a subject matter expert (SME) capacity locally/globally.
- Demonstrates track record in quality decision-making and problem resolution. Able to set and manage priorities, resource and performance targets of local study deliverables. As required, assists with audits/inspections of local clinical operations department and study / sites in the US.
- Accountable to estimate, track and deliver against the local budget for the studies within their scope of responsibility.
- Provides feedback on performance, capabilities and competencies of study members to line management. Stakeholder management skills required as the role includes interactions with external clinical site staff and senior stakeholders at a central or local level.
- Ensures that critical study timelines related to study activities are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides trouble-shooting and problem resolution support for US team to ensure productive, efficient study delivery.
- Has the curiosity to understand the why and the courage to challenge the how. Acquires and maintains an appropriate level of knowledge on the study compound, protocol, study indication(s), pathology of disease area being studied, competitive landscape within the US, local treatment/immunization guidelines and local health care system requirements.
- Excellent matrix leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives. Recognizes and reacts to changes that impact a study and/or program or practices, and has the skill set to assess the appropriateness of protocol/plans in the local environment.
- Proactively identifies, resolves, or escalates issues and risks that could impact study delivery, and implements effective mitigation strategies. Takes a
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