Plan and manage overall activities for assigned global clinical trial(s)
Lead and manage cross-functional Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices
Work closely with the Clinical Science Experts and Clinical Scientist for the design of the clinical trials
Establish project milestones, budget and timelines for the study in partnership with the Clinical Trial Team and outsourcing manager
Manage clinical trial progress and ensure completeness of documentation and data collection in adherence with the project timelines
Proactively identify potential risks and develop & implement action plans to avoid or mitigate program risks
Contribute to the reporting of clinical studies and clinical documentation to regulatory submissions according to plan and in compliance with applicable regulatory requirements, international standards and the company quality system throughout the development life cycle
Manage Contract Research Organizations (CROs) and Functional Service Providers (FSPs)
Collaborate with Procurement to prepare clinical outsourcing specifications
Serve as the primary trial contact with the CRO and FSPs

Requirements

University degree required in Life Sciences such as biology, pharmacology, nursing, or health sciences
Progressive experience in clinical research/operations (at least 5 years)
Experience from all parts of the clinical trial process, from protocol development to the compilation of study reports
Experience as manager of clinical trials in major market(s) such as US, China
Experience in supervising CROs.
Excellent understanding of the drug development process, systemic drug and biologics experience preferred
Excellent knowledge of international ICH/GCP guidelines, basic knowledge of GMP/GDP
Excellent knowledge of relevant local regulations
Fluent in English (written and oral)

Benefits

Health insurance
401(k) plan with employer match
Generous paid time off policy
Hybrid work schedules
Opportunity to participate in an annual short-term incentive program

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical trial managementprotocol developmentdata collectionrisk managementregulatory submissionsclinical documentationdrug development processsupervising CROsbudget managementproject milestone establishment

Soft Skills

leadershipcross-functional collaborationcommunicationproblem-solvingorganizational skillsproactive identification of risksteam managementadaptabilityattention to detailtime management