Contribute to the planning, implementation, and execution of global clinical trials.
Plan, execute, and lead study-specific meetings (e.g., internal core team meetings, investigator meetings, etc), as needed.
Provide input for the design of the 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 completion of study deliverables.
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 at clinical trial sites.
Collaborate with the data management team to ensure data integrity and timely database lock.
Ensure tracking, review of protocol deviations, and assess impact on study data.
Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review.
Partner with Operational Excellence and assigned Site Engagement Leads to help drive site engagement and bolster recruitment
Serve as key counterpart of Clinical Outsourcing to build RFPs and support the selection of clinical vendors
Oversee and contribute to Sponsor Oversight activities including but not limited to review of KPIs, KRIs, PDs, risks, Data Review Findings, etc. to assess the health of the study and proactively ensure mitigations are in place to achieve Company’s quality standards
Contribute to clinical operations process improvement initiatives
Maintain accurate and complete trial documentation.
Proactively identify and resolve clinical project issues.
This role may require up to 25% travel
Skills and experience you’ll bring:
BS degree and 8+ years of experience in clinical operations in biotech/pharma. 5 years’ experience leading global clinical trials
Inspection readiness experience preferred
Experience working on large, global, complex phase 2b/3 or late stage trials. Respiratory or Immunology experience highly preferred.
Broad knowledge of Global regulations and guidelines including CFR, ICH GCP, HIPAA, GDPR, and the Protection of Human Research Subjects.
Strong project management skills with the ability to manage multiple trials simultaneously.
Excellent problem-solving, leadership, and communication skills.
Ability to work in a fast-paced, dynamic environment with cross-functional teams.