Hybrid Associate Clinical Trial Manager: Study Leadership

Keenova Therapeutics plc; Malvern (Chester County); Hybrid; USD 95,000 - 125,000; Full time

Job summary

Keenova Therapeutics plc is seeking an Associate Clinical Trial Manager in Malvern, PA to support clinical operation leadership across one or more study teams. The role emphasizes adherence to GCP/ICH, regulatory standards, and Keenova SOPs while managing budgets, timelines, and vendor relationships.

You will collaborate with CTMs, leads, and external partners to develop study execution plans, oversee TMF, and coordinate site selection, start-up, and close-out activities, ensuring high-quality

Qualifications

• BS degree in biology, allied health, nursing or related life science; 3+ years related experience in clinical study execution.
• In-depth knowledge of clinical drug development processes and GCP/ICH/FDA regulatory requirements.
• Ability to develop and implement study processes, risk management and vendor oversight.

Responsibilities

• Lead cross-functional study teams and assist the Clinical Trial Manager in study setup.
• Develop study execution plans, risk management plans, and ICFs with input from functional leads.
• Oversee TMF maintenance and regulatory document reviews.
• Manage CRO/vendor selection, contracting, oversight and KPI monitoring.
• Coordinate site selection, initiation, monitoring, and close-out activities.
• Ensure adherence to GCP/ICH and SOPs, and manage study budgets and timelines.
• Provide training and mentorship to CTAs and study staff.
• Prepare and review study documents including monitoring plans and eCRF specifications.

Skills

Cross-functional leadership

Budget management

GCP & ICH knowledge

Communication

Study planning & execution

Vendor management

Mentoring CTAs

Project timelines

Education

BS degree in biology, allied health, nursing or related life science

Advanced degree a plus

Tools

MS Word

Excel

Job description

Keenova Therapeutics plc is seeking an Associate Clinical Trial Manager in Malvern, PA to support clinical operation leadership across one or more study teams. The role emphasizes adherence to GCP/ICH, regulatory standards, and Keenova SOPs while managing budgets, timelines, and vendor relationships.

You will collaborate with CTMs, leads, and external partners to develop study execution plans, oversee TMF, and coordinate site selection, start-up, and close-out activities, ensuring high-quality