Clinical Trial Manager

• Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out
• Successful execution of assigned trials and ensuring completion of trial deliverables
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members
• Mentoring and training of team members
• Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor
• Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities
• Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction

Qualifications:

Minimum Required:

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field, including experience in the field of oncology

Other Required:

• Demonstrable experience leading clinical aspects of your studies across multiple countries in a CRO / Pharma or Biotech company (in a dedicated 'clinical lead' role).
• Significant clinical trial management experience in the area of oncology
• Working knowledge of GCP/ICH guidelines and the clinical development process
• Availability for domestic and international travel including overnight stays
• Must be able to communicate effectively in the English language

Skills:

• Demonstrated computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)
• Demonstrated ability to develop positive working relationships with internal and external organizations
• Demonstrates core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan

Competencies:

• Demonstrates mastery knowledge of ICH-GCP, meaningful Precision SOPs, and regulatory guidance, as well as the ability to implement

Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.

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