How youβll make an impact:
- Contribute to the planning, implementation, and execution of global clinical trials.
- Plan, execute, and lead study-specific meetings (internal core team, investigator meetings, etc.).
- Provide input for design of Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc.
- Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites, and other contract personnel.
- Manage study timelines and metrics to ensure delivery of study objectives.
- Lead site feasibility and selection qualification, initiation, and oversight of outsourced monitoring activities.
- Review monitoring reports to ensure quality and resolution of site-related issues.
- Ensure timely enrollment and data collection.
- Collaborate with data management to ensure data integrity and timely database lock.
- Track and review protocol deviations and assess impact on study data.
- Work with translational medicine on bioanalytical sampling plan incorporation and data output for functional groups.
- Partner with Operational Excellence and Site Engagement Leads to drive site engagement and recruitment.
- Serve as Clinical Outsourcing counterpart to build RFPs and support vendor selection.
- Oversee Sponsor Oversight activities (e.g., review KPIs/KRIs/PDs/risks, Data Review Findings) to ensure mitigations meet quality standards.
- Contribute to clinical operations process improvement initiatives.
- Maintain accurate and complete trial documentation.
- Proactively identify and resolve clinical project issues.
- Travel up to 25%.
Skills and experience youβll bring:
- BS degree; 8+ years clinical operations experience in biotech/pharma; 5 years leading global clinical trials.
- Inspection readiness experience (preferred).
- Experience with large, global, complex phase 2b/3 or late-stage trials; Respiratory or Immunology experience (highly preferred).
- Knowledge of global regulations/guidelines: CFR, ICH GCP, HIPAA, GDPR, Protection of Human Research Subjects.
- Strong project management; ability to manage multiple trials.
- Excellent problem-solving, leadership, and communication skills.
- Ability to work in fast-paced, cross-functional environment.