(Senior) Clinical Trial Manager
- Developing operational plans, charters, and trial manuals.
- Reviewing trial protocols, amendments, and other critical trial documents.
- Leading the creation of the Trial Oversight Plan and Global Master ICF, including amendments.
- Coordinating site selection with the Start-Up team, reviewing regulatory documents, and approving site activations.
- Overseeing vendor management, including vendor deliverables, and ensuring alignment on trial activities.
- Supporting trial execution by managing protocol deviations, tracking KPIs/KQIs, resolving site issues, and participating in Risk-Based Quality Management (RBQM) activities.
- Collaborating with cross-functional teams to address escalations and ensure timely issue resolution.
- Participating in inspection readiness, audits, and site monitoring oversight activities as needed.
- Experience: A Bachelor's or master's in medical, biological, or pharmaceutical sciences (or equivalent). With 5-7 + years of experience in clinical trial management from a pharmaceutical company and/or CRO, ideally within oncology or first-in-human trials.
- Expertise: Strong knowledge of trial execution, GCP, and clinical drug development, with experience operating in a global setting.
- Skills: Exceptional communication skills (written and verbal), risk management abilities, and stakeholder management.
- Soft Skills: A proactive problem solver who identifies risks and develops effective mitigations. A collaborative leader with a quality mindset, adaptability in fast-paced environments, and the ability to inspire trust.
- You are genuinely passionate about our purpose
- You bring precision and excellence to all that you do
- You believe in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
- You take pride in enabling the best work of others on the team
- You can grapple with the unknown and be innovative
- You have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so!
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