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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead cross-functional study teams as the primary point of contact for assigned studies
- Provide operational input into protocol development and key study documents
- Lead feasibility assessments, site evaluation and selection, investigator meetings, and patient recruitment and retention strategies
- Select, contract, and oversee CROs and third-party vendors
- Manage study budgets and timelines, identify risks, and escalate issues with mitigation plans
- Oversee data quality, protocol deviations, CTMS, and TMF to keep studies audit and inspection ready
- Manage study close-out activities and contribute to clinical study reports and lessons learned
- Supervise, coach, and develop Clinical Trial Management staff
- Drive innovation and process improvement across the department
Requirements
What you’ll need- Bachelor’s degree and 8+ years of relevant clinical trial experience
- Extensive experience in global clinical trial operations
- Knowledge of ICH/GCP and regulatory guidelines
- Line management experience
- Ability to build, lead, and develop productive study teams
- Strong budget management, vendor management, and negotiation skills
- Exceptional interpersonal, communication, and influencing skills
- Preferred: Advanced proficiency in trial management systems (CTMS, EDC, IVRS/IWRS) and MS applications
- Preferred: Awareness of relevant industry trends and experience driving process improvement
- Ability to travel up to 25%
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process where required
