Clinical Trial Operations Specialist

Actalent; Bala Cynwyd (PA); Hybrid; USD 62,000 - 76,000; Full time

Benefits offered by this job

Medical coverage

Dental & vision coverage

Life Insurance

Disability insurance

401(k) retirement plan

Transportation benefits

Time Off / PTO

Job summary

Actalent is seeking a Clinical Trial Associate in Bala Cynwyd, PA, to support trial startup, execution, and closeout in a hybrid on-site role. You will work under the Director of Clinical Operations and ensure SOP/compliance with regulatory requirements while assisting study managers and CRO oversight.

The role requires a bachelor’s degree and at least 3 years in pharmaceutical drug development and clinical operations, plus experience with eTMF/TMF and Veeva, and strong MS Office skills.

Qualifications

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

Responsibilities

• Provide general administrative support to the Clinical Operations Department and assistClinical Study Managers.
• Support clinical studies and manage agendas, minutes, study tracking, and IRB correspondence.
• Assist CSOs with CRO/vendor oversight, document review, and quality control (protocol, ICF, study plans, CRFs).
• Help implement TMF specifications to align with program milestones.
• Assist in filing documents in the TMF and conduct quality reviews.

Skills

Clinical trial experience

Clinical research proficiency

eTMF knowledge

TMF knowledge

Veeva

Microsoft Office

BLA Submission experience

Sponsor CTA experience

Sponsor experience

Inspection Readiness

Site Management experience

Data review experience

Fast-paced environment

Education

Bachelor's degree

Tools

Veeva

Microsoft Office

Job description

Actalent is seeking a Clinical Trial Associate in Bala Cynwyd, PA, to support trial startup, execution, and closeout in a hybrid on-site role. You will work under the Director of Clinical Operations and ensure SOP/compliance with regulatory requirements while assisting study managers and CRO oversight.

The role requires a bachelor’s degree and at least 3 years in pharmaceutical drug development and clinical operations, plus experience with eTMF/TMF and Veeva, and strong MS Office skills.