Clinical Trial Manager

Posted about 1 month agoViewed

💎 Seniority level: Manager, 7 + years

📍 Location: United States

🔍 Industry: Biopharmaceutical

🗣️ Languages: English

⏳ Experience: 7 + years

🪄 Skills: Project ManagementData AnalysisCross-functional Team LeadershipBudget management

BA/BS degree with 7+ years of experience supporting and independently managing clinical trial activities.
Strong knowledge of ICH/GCP and regulatory requirements.
Strong experience in the drug development process including trial design and management.
Excellent verbal and written communication skills.
Proven ability to work effectively across functions.
Ability to travel approximately 20% of the time.

Ownership of all operational aspects of clinical trials, including CRO and vendor management.
Lead and/or support study activities, including vendor evaluation and selection, country and site selection, informed consent development and maintenance, eCRF design and implementation, protocols, study plans and manuals, IBs, CSRs.
Proactively identify and support resolution/escalation of trial conduct-related issues.
Manage and lead cross-functional trial teams, including collaborating with internal team members and external vendors for the planning and execution of clinical trials, through closeout.
Provide regular up-to-date trial information and updates on trial progress/performance to internal stakeholders.
Oversee clinical monitoring from site qualification to closure visits to assure data integrity.
Oversee the review/cleaning and reconciliation of all clinical data to support timely database lock.
Partner with stakeholders to develop and implement study-specific training to relevant personnel.
Support development of department documentation, such as SOPs.
Help develop and maintain study budgets.

Posted about 1 month ago

📍 United States of America

🔍 Clinical Research Organization (CRO)

Bachelor’s Degree or a Nursing Degree required.
2+ years’ experience as a Clinical Trial Manager, Clinical Operations Leader, Lead CRA, or equivalent role.
3+ years’ experience as a Clinical Research Associate.
Experience in Neurology required.
Willingness to travel up to 30%.
Proficiency in Microsoft Office, CTMS, and EDC Systems.
Excellent interpersonal, oral, and written communication skills in English.
Ability to lead and motivate a team remotely.
Demonstrate initiative and problem-solving skills.

Provide leadership and direction to clinical site management team members from study start through to closure.
Serve as the primary point of contact and representative for clinical monitoring and site activities within the project.
Manage monitoring deliverables to achieve study budget and identify Out of Scope Activities.
Oversee compliance to the Clinical Monitoring Plan, including site visits, outstanding trip reports, and follow-up letters.

LeadershipProject ManagementMicrosoft Office

Posted about 1 month ago

🔧 Requirements