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

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical study managementclinical trial managementvendor managementGCPSOPsprotocol developmentstudy document preparationdata verificationclinical monitoringbiopharma industry experience

Soft Skills

strong communication skillsrelationship buildingstrategic direction communicationcross-functional collaborationleadershiporganizational skillsproblem-solvingteam managementnegotiation skillsadaptability