Clinical Trial Manager/Local Delivery Lead

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

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.

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.

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

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.

As required, prepares the local Informed Consent Form and coordinates the submission of Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study.

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.

Why You? Basic Qualifications:

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

Bachelor’s degree: BA or BS OR 10+ years of clinical/clinical operations experience

At least 5 years’ experience as a local trial manager/local delivery lead managing Oncology Medicine trials.

Phase I-III Medicines trial experience with solid operational knowledge of clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug development process.

Experience with leading and managing multiple complex design studies such as master protocols of umbrella, basket and platform trial designs.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

Master of Science, PhD or equivalent coupled with previous project management experience.

Preferred experience supporting or leading unblinded clinical trials, including management of unblinded vendors, processes, and site activities.

Effective problem solving, negotiation and conflict resolution skills in a matrix environment

Deep knowledge of human research regulations in the US, IND/GCP/ICH-guidelines and GSK SOP/POL/guidelines

Available and willing to travel as job requires.

Strong written and verbal communications skills.

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