Associate Clinical Trial Manager: Hands-on Trial Operations

Mallinckrodt Pharmaceuticals; Malvern (Chester County); Hybrid; USD 90,000 - 125,000; Full time

Job summary

Keenova is seeking an Associate Clinical Trial Manager to lead cross-functional study teams and ensure trials are conducted on time, within budget, and with high quality in line with GCP and FDA guidelines.

The role collaborates with Clinical Trial Manager and leads vendor management, TMF maintenance, and study documentation. A BS in life sciences and 3+ years of study execution experience are required.

Qualifications

• BS degree in biology, allied health, nursing or related life science is required.
• Advanced degree is a plus and may strengthen candidacy.

Responsibilities

• Execute startup, conduct, close-out activities with input from stakeholders.
• Monitor assigned study aspects for timelines, budget, and quality.
• Manage operational study budget, timelines and risk mitigation.
• Process input from key stakeholders and ensure regulatory compliance.
• Support development and application of standardized study processes and metrics.
• Maintain study TMF and oversee vendor management and CRO oversight.

Skills

Study management

Cross-functional collaboration

Communication

Risk management

Project planning

Education

BS degree in biology or related life science

Advanced degree a plus

Tools

MS Word

Excel

Job description

Keenova is seeking an Associate Clinical Trial Manager to lead cross-functional study teams and ensure trials are conducted on time, within budget, and with high quality in line with GCP and FDA guidelines.

The role collaborates with Clinical Trial Manager and leads vendor management, TMF maintenance, and study documentation. A BS in life sciences and 3+ years of study execution experience are required.