Clinical Trial Operations Specialist

Actalent; United States; Hybrid; USD 62,000 - 76,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account

Job summary

Actalent is seeking a Clinical Trial Associate to support the Clinical Operations team in Bala Cynwyd, PA. The role involves trial startup, execution, and closeout activities to ensure quality and regulatory compliance.

You will assist Clinical Study Managers, manage study documentation, and coordinate with CROs and vendors in a fast-paced environment. The ideal candidate has at least 3 years of pharmaceutical development and experience with ICH-GCP, TMF, and eTMF processes, plus proficiency in

Qualifications

• Bachelor's degree required.
• Minimum 3 years of pharmaceutical drug development and clinical operations experience.
• Knowledge of the drug development process and regulatory requirements.
• Understanding of ICH-GCP, GDP, SOPs and FDA CFR compliance.

Responsibilities

• Provide general administrative support to Clinical Operations and assist Clinical Study Managers.
• Support studies and manage tasks like agendas, minutes, study tracking, and IRB communications.
• Assist with CRO/vendor oversight, document reviews, and quality control of study materials.
• Help implement TMF specifications and conduct quality reviews of TMF documents.
• Assist in document filing in the electronic TMF and ensure compliance.

Skills

Clinical trial experience

Sponsor CTA experience

BLA submission

ICH-GCP familiarity

Education

Bachelor's degree

Tools

Veeva

Microsoft Office

Job description

Actalent is seeking a Clinical Trial Associate to support the Clinical Operations team in Bala Cynwyd, PA. The role involves trial startup, execution, and closeout activities to ensure quality and regulatory compliance.

You will assist Clinical Study Managers, manage study documentation, and coordinate with CROs and vendors in a fast-paced environment. The ideal candidate has at least 3 years of pharmaceutical development and experience with ICH-GCP, TMF, and eTMF processes, plus proficiency in