Manager, Trial Delivery Management

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OneTrust

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

📋 Compliance

☁️ SaaS

🏢 Enterprise

💰 $150M Series D - OneTrust on 2023-07

Compliance • SaaS • Enterprise

OneTrust is a company that provides a privacy, security, and governance software platform. Its cloud-based (SaaS) offering helps organizations manage data privacy, consent, regulatory compliance, vendor/third-party risk, and related governance and security processes, primarily for enterprise customers.

📋 Description

• Execute study-level trial delivery activities • Create and update trial-specific documents, including Monitoring Guidelines, Informed Consent Forms, and Investigational Medicinal Product documentation • Set up and manage day-to-day study vendor activities, including statements of work and budget oversight • Coordinate and oversee country- and regional-level trial management activities • Align feasibility strategy with local teams and perform country-level risk reviews • Support development of program-level compound training with Clinical and CTL&D Medical Writing • Provide input into trial-level operational strategies • Resolve trial-related issues and mitigate trial-related risks • Participate in process improvement activities at trial, compound, and cross-DU levels • Support Health Authority inspections and program-level risk identification and mitigation planning • Mentor and support onboarding of new Trial Management team members • Foster employee engagement, inclusion, and Credo Behaviors

🎯 Requirements

• BS degree or equivalent; preferred areas of study include Life Sciences such as Biology, Chemistry, Biochemistry, Nursing, or Pharmacy • Minimum of 8 years in pharmaceutical, healthcare, or related industries • Experience and knowledge of the pharmaceutical development process • Clinical research operational knowledge and experience across multiple study phases (Phase I-IV) • Ability to manage all aspects of clinical trial execution • 2-3 years of experience leading multiple aspects of a global clinical trial • Excellent leadership skills and ability to foster team productivity and cohesiveness • Experience leading without authority in multifunctional, matrixed, and global environments • Excellent decision-making, analytical, and financial management skills • Ability to operate and execute with limited supervision • Experience mentoring/coaching others • Strong project planning/management, communication, and presentation skills • Willingness to travel up to 15-20% of the time • Preferred related industry experience: Pharmaceutical, Biopharmaceutical, Biotechnology

🏖️ Benefits

• Remote work options may be considered on a case-by-case basis and if approved by the Company • Travel up to 15-20% of the time, defined by business needs • Inclusive work environment • Interview process accommodations for applicants with disabilities