Remote Senior/Clinical Trial Manager
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We are partnered with a rapidly growing stealth mode biotech that is passionate about combining expert knowledge with best-in-class approaches to improve the health of patients with life threatening diseases. They have an exciting pipeline including 2 Phase II cardiovascular trials targeted to get kicked off early next year.
As a result, they are hiring for Senior/Clinical Trial Managers for a pivotal role managing multi-center global clinical trials.
This role is fully remote with location preference for the northern New Jersey area as they are planning to open an office later this year.
In addition to contributing to the clinical operations department initiatives, you will also be responsible for:
Responsibilities
- Coordinates internal and external clinical trial management activities, including study planning, start up, conduct, and closure of assigned clinical trials
- Manages implementation of the study level operational strategy for clinical study execution
- Oversees delivery of studies by CROs to ensure quality execution consistent with time and budget
- Leads study meetings to drive study execution (Internal, CRO, Third Party Vendors, etc.)
- Proactively identifies study risks and implements contingency plan
- Ensures effective, consistent, efficient, and compliant processes
- Provide training and mentorship to junior Clinical Operations staff
Your profile:
- Bachelor's degree in life sciences or related discipline
- Excellent attention to detail
- 4-10 years in clinical operations management, overseeing outsourced clinical trials per quality, timeline, and budget expectations
- Related scientific and clinical expertise and strong project-management, risk-assessment, contingency-planning, and communication skills
- Knowledge of clinical development related to one or more trial phases (I, II, III, or IV), as well as cross-functional drug development
- Versed in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development
- Effective CRO management skills and ability to flex with an ever-changing startup environment
- Strong interpersonal and communication skills to effectively articulate study needs & activities
- Proficiency in Microsoft Office applications including Outlook, Excel, Word, and PowerPoint
~Questions? Please contact me at elizabeth.wall@ or (206) 453-6393~