| 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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