Staffing Theory · 1 day ago
Senior Clinical Trial Manager
United States
Full-time
Remote
Senior Level, Lead/Staff
8+ years expStaffing Theory is seeking a Senior Clinical Trial Manager who will be accountable for operational planning and execution of clinical studies. The role involves overseeing interactions with CROs and vendors, ensuring that study milestones are met according to quality standards and timelines.
Staffing & Recruiting
No H1B
Responsibilities
Accountable for overall or regional management of assigned clinical trial(s)
Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols
Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, close out, and completion of Trial Master File
Demonstrates consistent and regular Sponsor Oversight and performance management for all utilized vendors and/or CRO third party contracted vendors
Responsible for accurate drug accountability/reconciliation for investigational product (IP) issued during the trial to the site and at the end of the trial
Responsible for ensuring sufficient ancillary supplies are available and shipped for the trial (i.e., templates, binders, forms, supplies, etc.)
Proactively identify and resolve issues that arise during the course of the trial, maintaining a sense of urgency and attention to detail
Works cross-functionally to establish and ensure clinical trial timelines and goals are met and risks are appropriately escalated to Management
Ability to travel 25% including possible international travel
Qualification
Required
MUST HAVE EXPERIENCE WITH CARDIOLOGY OR PULMONARY STUDIES
Bachelor's degree required, with a minimum of 8-10 years of experience within the pharmaceutical/biotech industry as a clinical monitor
Experience with Phase I-III global trials
Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight
Experience working in a fast-paced and dynamic environment
Ability to travel 25% including possible international travel
Company
Staffing Theory
Staffing Theory is a niche recruiting partner for the biopharma industry.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase