Clinical Project Manager - Oncology

Salary: 120000 / Yearly	Location: Cambridge, MA
Type: Full-Time	Postal Code: 02140

Clinical Project Manager - Oncology

This position is responsible for coordinating and managing all aspects of clinical trial activities to maintain compliance with regulations, meet study timelines and goals, train and monitor study site(s) for compliance with study protocols and procedures, and data quality assurance.

The CPM will be involved with the selection, training and initiation, audit, and close-out activities of the clinical sites in accordance with appropriate regulations. This position is also responsible for the design, preparation, and presentation of study materials including procedure manuals, informed consents and HIPAA documents, and study reports.

The Clinical Project Manager collaborates and coordinates with external organizations including study sites, contract research organizations (CROs), and institutional review boards (IRBs), Legal, Regulatory, and Biometrics. Additionally, the CPM may be responsible for training and mentoring new hires and project staff as well as oversee the work of CRAs.

Responsibilities include but are not limited to the following:
• Manages all study-related activities to meet defined study timelines while ensuring that GCP/ICH guidelines and the relevant SOPs are met
• Oversees investigator recruitment/selection and the conduct of trials at investigative sites
• Establishes vendor management plans and manages CROs and study-related vendors accordingly (inclusive of quality plan)
• Maintains primary responsibility for the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, safety plans, project management plans, communication plans, and quality plans
• Tracks study progress ensuring timely data collection, monitoring and, in collaboration with data management, internal listings reviews
• Manages and trains clinical research associates
• Reviews monitoring visit reports, informed consent forms, protocols and CRFs
• Participates in site visits, evaluating CROs/contract monitors through co-monitoring visits and/or site audits
• Provides Senior Management with regular study updates/status reports on study execution
• Acts as a liaison between departments for project-related matters

Qualifications
• BS/BA degree or equivalent (background in life sciences preferred). Advanced degree is preferred.
• 6 + yrs of industry experience (biotech/pharma/ CRO) with at least 2 years of project management experience
• At least 4 years monitoring experience, with ability to independently perform all types of monitoring visits
• Experience in managing global oncology trials from start-up to database-lock
• Experience in management of vendors and CRO's
• Strong understanding of ICH, GCP and relevant regulatory requirements
• Strong operational and management skills with attention to detail
• Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project
• Ability travel globally up to 20% of time

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