OneTrust

Lead Trial Delivery Manager – Oncology

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: Beerse • Belgium

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Job Level

Senior

About the role

  • 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.
Benefits
  • Flexible working arrangements
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial experienceclinical research operational knowledgeoncology clinical trial experienceCAR-T experiencebudget oversightrisk managementprogram-level compound trainingtrial management activitiesSOW creationfeasibility strategy
Soft Skills
leadership skillsteam productivitydecision-makinganalytical skillsfinancial management skillsmentoringproject planningproblem-solvingadaptabilityeffective communication