Lead, Trial Delivery Manager responsible for executing oncology clinical trials and managing vendor activities. Collaborate with local teams to ensure successful study delivery and compliance.
Responsibilities
Create and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation).
Manage vendor set up and management of day-to-day study vendor activities, including set-up, SOW creation and budget oversight.
Responsible for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews, aware of all projects conducted across countries).
Support development of program-level compound training, collaborating with Clinical / CTL&T / Medical writing.
Provide input into trial level operational strategies.
Resolve trial-related issues and mitigate trial-related risks.
Participate in process improvement activities at a trial, compound & cross-DU level, as needed.
Provide support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.
Mentor & support onboarding of new team members, particularly those in Trial Management.
Requirements
BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries.
Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage multiple aspects of execution of a clinical trial.
2-3 years’ experience supporting multiple aspects of a global clinical trial.
Minimum of 2 years of oncology clinical trial experience.
CAR-T experience would be a plus
Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
Experience leading without authority and in multi-functional matrixed and global environments.
Excellent decision-making, analytical and strong financial management skills are essential to this position.
Operate and execute with limited supervision.
Experience mentoring/coaching others.
Strong project planning/management, (e.g. organization, problem-solving, and adaptability) communication (e.g. effective communication with and managing expectations of stakeholders) and presentation skills are required.
Ability to think strategically and work through ambiguous situations.
Ability and experience to lead the Study Management Meetings.
Experience and skills utilizing technology (e.g. tools, systems with GenAI enabled capabilities) to obtain reports for efficient metric oversight.
Travel up to 15-20% of the time, defined by business needs.
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