Clinical Trial Manager
Our client is a biotechnology company aimed at developing medicines targeting metabolic and age-related disorders. They have asked us to assist them in a search for a Clinical Trial Manager.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- 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.
- A Bachelor’s degree in life sciences or related discipline is required.
- Must have three to five years in clinical operations management, overseeing outsourced clinical trials per quality, timeline, and budget expectations.
- Must have excellent attention to detail.
- Related scientific and clinical expertise and strong project-management, risk-assessment, contingency-planning, and communication skills are required.
- Requires knowledge of clinical development related to one or more trial phases (I, II, III, or IV), as well as cross-functional drug development.
- Must be versed in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development.
- Requires effective CRO management skills and the ability to flex with an ever-changing startup environment.
- Must have strong interpersonal and communication skills to effectively articulate study needs and activities.
- Must be proficient in Microsoft Office applications including Outlook, Excel, Word, and PowerPoint.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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