Senior Clinical Trial Manager managing global Phase 3 clinical trials for oncology at Verastem Oncology. Overseeing vendor management, budget adherence, and regulatory compliance throughout the project lifecycle.
About the role
- Clinical Scientist Director supporting early phase clinical development at AMGEN. Collaborating to translate scientific strategy into actionable execution across clinical trials.
Responsibilities
- Support early phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials.
- Serve as a key clinical development team member, providing hands-on oversight of protocol execution, medical data review, and clinical data quality.
- Work collaboratively within cross-functional teams to ensure clinical trials are executed in alignment with protocol intent, regulatory expectations, and Amgen quality standards.
- Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity.
- Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues.
- Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams.
- Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects.
- Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents.
- Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval.
- Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results.
- Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements.
- Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle.
Requirements
- Doctorate degree and 4 years of life sciences/healthcare experience OR Master’s degree and 7 years of life sciences/healthcare experience OR Bachelor’s degree and 9 years of life sciences/healthcare experience
- 5 years of pharmaceutical clinical drug development experience
- Strong preference for individuals with proven track record of clinical trial process improvement
- Industry or academic experience in early-phase drug development within Inflammation
- Strong communication & presentation skills in English to clearly communicate scientific concepts/data to leadership committees both internally or externally (both written and oral)
- Experience with designing, monitoring, and implementing clinical trials for Inflammation and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
- Understanding of conducting study data readout activities, including data cleaning, database lock, data extract, producing outputs of data
- Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
- Serving as a contributing author to scientific publications and data presentations at scientific conferences
- Experience in clinical data analysis such as Spotfire or other data analysis tools.
Benefits
- Vast opportunities to learn, develop, and move up and across our global organization.
- Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.
- Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.
- Flexible work arrangements.
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