Senior Clinical Trial Manager – Imaging Study
Job Description:
• Leads the Clinical Study Team for assigned projects; may lead one or more clinical studies, from concept to protocol, and achieve corporate objectives and key milestones such as First Patient In, Interim Analysis, Database lock, etc.
• Manage external vendors and contract research organizations, may manage internal resources such as Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)
• Prepare/Review/Approve study documents such as the Monitoring Manual, Study Operational Manual, Source Data Verifications Plan, and Laboratory Manual
• Coordinate and design study materials such as CRFs, patient diaries, study participation cards, and source documents.
• Manage operational activities at the study level and monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to GCP, Standard Operating Procedures (SOPs), and study protocols
• Negotiate and manage vendor work agreements and site contracts
Requirements:
• Bachelor’s degree in a scientific discipline or equivalent is required, and an advanced degree is preferred
• Requires at least eight years of biopharma industry experience (relevant clinical trials experience, in the biotechnology, pharmaceutical, CRO, medical device industry) with at least two years managing clinical trials
• Must have vendor management experience in clinical operations/development
• Strong verbal and written communication skills, can communicate strategic direction and relevant context so that employees at all levels understand their role in achieving success
• Ability to build and maintain strong working relationships within the department and cross-functionally to meet a project or corporate goal
• Experience with Microsoft Office Suite required (Word, Excel, Project, Outlook)
• Must be able and willing to travel periodically
Benefits:
• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability
• Subsidized lunch via Forkable on days worked from our office
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• Leads the Clinical Study Team for assigned projects; may lead one or more clinical studies, from concept to protocol, and achieve corporate objectives and key milestones such as First Patient In, Interim Analysis, Database lock, etc.
• Manage external vendors and contract research organizations, may manage internal resources such as Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)
• Prepare/Review/Approve study documents such as the Monitoring Manual, Study Operational Manual, Source Data Verifications Plan, and Laboratory Manual
• Coordinate and design study materials such as CRFs, patient diaries, study participation cards, and source documents.
• Manage operational activities at the study level and monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to GCP, Standard Operating Procedures (SOPs), and study protocols
• Negotiate and manage vendor work agreements and site contracts
Requirements:
• Bachelor’s degree in a scientific discipline or equivalent is required, and an advanced degree is preferred
• Requires at least eight years of biopharma industry experience (relevant clinical trials experience, in the biotechnology, pharmaceutical, CRO, medical device industry) with at least two years managing clinical trials
• Must have vendor management experience in clinical operations/development
• Strong verbal and written communication skills, can communicate strategic direction and relevant context so that employees at all levels understand their role in achieving success
• Ability to build and maintain strong working relationships within the department and cross-functionally to meet a project or corporate goal
• Experience with Microsoft Office Suite required (Word, Excel, Project, Outlook)
• Must be able and willing to travel periodically
Benefits:
• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability
• Subsidized lunch via Forkable on days worked from our office
Apply tot his job
Apply To this Job