Join our Talent Community- Clinical Trial Manager

About You

• You have a passion for bringing lifesaving and lifealtering treatments to market
• You love having responsibility and a say in how clinical trials are run
• You plan ahead but have alternative options in case things go wrong
• Last minute requests and shifting priorities don't rattle you
• You are extraordinary at handling study timelines while never sacrificing quality
• You communicate clearly, often, and concisely and know that your role is crucial in keeping the trial running smoothly
• You are a master at identifying any risks that threaten projects and handle them resolutely
• You thrive with minimal direction and happily take responsibility for the outcomes of your work
• You are a team player and thrive working in a collaborative environment

Qualifications

Minimum Required

• Bachelor's degree or equivalent combination of education/experience in science or health-related field
• Clinical Trial Lead/Manager: Minimum of 5 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience. Prefer at least 2 years of CTM experience at a CRO, Pharma or Biotech company.
• Senior Clinical Trial Lead/Manager: Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience. Prefer at least 4 years of CTM experience at a CRO, Pharma or Biotech company.

Other Required

• Moderate independent field monitoring experience
• Clinical team lead or comparable supervisory experience
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
• Experience with various EDC and eTMF systems
• Excellent communication and interpersonal skills to effectively interface with others in a team setting
• Excellent organizational skills, attention to detail, and a customer service demeanor
• Availability for domestic and international travel, including overnight stays

Skills

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

Including, but not limited to

• Demonstrates mastery knowledge of ICH-GCP, and regulatory guidance, as well as the ability to implement
• Working knowledge of clinical management techniques and tools
• Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
• Results-oriented, accountable, motivated, and flexible
• Excellent time management, negotiation, critical thinking, decision making, analytical, and interpersonal skills
• Direct work experience in a cross-functional environment
• Excellent presentation, verbal, and written communications skills
• In-depth proven experience in pharmaceutical and/or device research required

Additional information

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