Associate Clinical Trial Manager: Study Delivery

Mallinckrodt; Malvern (Chester County); On-site; USD 110,000 - 140,000; Full time

Job summary

Mallinckrodt in Malvern, PA seeks an Associate Clinical Trial Manager to assist the Clinical Trial Manager in leading study teams, ensuring studies are delivered on time, within budget, and with high quality, in compliance with GCP and ICH.

The role collaborates with the Clinical Development Lead, Data Management Lead, Regulatory Lead, Clinical Supply Lead, Biostatistics Lead, and Medical Writing Lead; supports TMF maintenance and vendor oversight, including CROs and labs.

Qualifications

• GCP knowledge and ICH guidelines awareness required.
• Experience with budget planning and cost control for clinical studies.
• Vendor management experience including CROs and central laboratories preferred.

Responsibilities

• Execute and oversee study activities with adherence to GCP, ICH, and Keenova SOPs.
• Monitor and manage study budgets, timelines, and risk mitigation.
• Coordinate with cross-functional teams and external vendors to ensure on-time deliverables.
• Maintain and oversee study documentation and TMF."
• Support study planning, site selection, and vendor oversight.

Skills

GCP knowledge

ICH guidelines

Budget management

Vendor management

Cross-functional coordination

Job description

Mallinckrodt in Malvern, PA seeks an Associate Clinical Trial Manager to assist the Clinical Trial Manager in leading study teams, ensuring studies are delivered on time, within budget, and with high quality, in compliance with GCP and ICH.

The role collaborates with the Clinical Development Lead, Data Management Lead, Regulatory Lead, Clinical Supply Lead, Biostatistics Lead, and Medical Writing Lead; supports TMF maintenance and vendor oversight, including CROs and labs.