Associate Director, Clinical Trial Manager

This is a remote home-based role for applicants eligible to work in the United States.

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 Manager/Local Delivery Lead -Oncology provides leadership, oversight and manages the activities of operational planning and delivery of Phase I-IV Oncology clinical trials in the United States to the required quality standards, GSK written standards, local regulations and ICH GCP. In a senior capacity, act as a role model, coach, mentor for less experienced CTM/LDLs on processes, technical and behavioral competencies.

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.    

• Serves as the operational point-of-contact between the central GSK study team and US study team. The CTM/LDL collaborates closely with local medical and regulatory affairs staff to align on local medical and scientific requirements

• Accountable for delivery of assigned studies to recruitment targets, diversity targets, time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH guidelines, GSK Corporate, and local SOPS and POLs.    

• Demonstrates the ability to effectively manage multiple priorities and responsibilities of increased scope and complexity.   

• 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.

• Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders.   

• Identifies and resolves or escalates issues and risks that may impact study delivery. Takes a leadership role in identifying the root cause of issues, implementing/influencing corrective and preventative actions locally or at a broader study level.   

• Provides feedback on performance, capabilities and competencies of study members to line management.

• Ensures appropriate site monitoring activities have been completed per the study monitoring plan and reviews/ approves monitoring visit reports.

• Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility.   

• As required, advises on contract development with Sites/CRO/Vendors and participates in budget/contract negotiations with study vendors or clinical investigator sites.    

• 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.   

• As required, assists with audits/inspections of local clinical operations department and study / sites in the US.   

• 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.   

• 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 role model, coach, mentor for less experienced CTM/LDLs on processes, study, technical and behavioral competencies. Provides training for new and less experienced CTM/LDLs as requi