Clinical Trial Manager

Job Description
Merrimack Pharmaceuticals is a high-energy biopharmaceutical company focused on the discovery and development of transformational medicines for complex disease, with an initial focus on cancer. Our work is founded on a revolutionary drug discovery platform that integrates high throughput quantitative proteomics, computational biology, and chemical engineering into a singular capability to dissect complex biological systems with unparalleled productivity. Merrimack is organized by multi-disciplinary project teams focused on the development and delivery of a novel therapeutic and companion diagnostic.

The Clinical Trial Manager will independently oversee clinical studies from concept to final close. The ideal candidate will be highly adaptable and a proactive problem-solver with the ability to critically evaluate and manage timelines and key deliverables.

Job Responsibilities:

Selecting and managing contract research organizations and other outside vendors to support clinical studies

Independently managing study activities, including: selection of investigators, study start-up activities including site initiation, study monitoring activities and data collection

Developing and managing study timelines

Contributing to the development of study related documents (contracts, ICFs, protocols, IBs, etc.)

Participating in review of CRFs and User Acceptance Testing data

Preparing clinical study budgets and tracking budgets for variances

Projecting study enrollment and drug supply

Managing study drug packaging and distribution activities

Providing portfolio support across the organization

Requirements:

BA/BS and 5 or more years of experience with direct clinical trial management, including management of vendors and CROs

Experience in Oncology clinical development is strongly preferred; Imaging and ex-US experience is a plus

Experience as a monitor is strongly preferred

Experience in clinical operations and/or early clinical development is strongly preferred

Working knowledge of GCP, ICH and relevant CFRs is required

Project management skills, effective communication (written and verbal), adaptability and self-motivation are required attributes

Approximately 10% travel, primarily involving trips to conferences for Investigator meetings or co-monitoring

Company

Merrimack Pharmaceuticals

Job Code

State or Province

Massachusetts

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