Project Manager/Monitoring Oversight Lead (PM/MOL)
Duties and Responsibilities:
The Project Manager (PM)/ Monitoring Oversight Lead (MOL) is responsible for managing one or more clinical trial(s) with emphasis on CRO & vendor management to drive a high functioning and results-driven team including timeline adherence, patient safety, adherence to contracted deliverables, the protocol and appropriate regulations and data integrity. In addition to providing primary PM responsibilities for his/her assigned clinical trial, the PM/MOL will provide Sponsor oversight of monitoring activities performed by Contract Research Organizations (CRO), and may perform monitoring, co-monitoring, site management and trial management activities for Phase II-IV clinical research projects.
The primary responsibilities for the PM/MOL include:
• Serve as primary Clinical Operations contact and resource for internal and external teams in assigned clinical study(ies). Assist in the selection of CROs, consultants and vendors and provide oversight of assigned vendors.
• Ensure oversight and compliance of internal team and outsourced vendors to ensure studies are conducted efficiently, effectively and in accordance with the protocol, GCP/ICH guidelines, FDA regulations and applicable SOPs.
• Track and report on the progress of assigned clinical trials including enrollment metrics and forecasts, budget and clinical timelines.
• Review and provide feedback on study protocols, assist in the design of case report forms, study manuals, study plans and other study documents
• Perform clinical trial management activities including identification of investigators, building relationships with investigators/trial site staff, development of Case Report Forms, Trial Master File oversight, implementation of enrollment and recruitment strategies
• Develop, execute, manage and ensure compliance of the Monitoring Plan.
• Provide Sponsor oversight of CRO monitoring, and site activities in accordance with the Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations.
• Review monitoring trip reports and track scheduling, report submission metrics, deviations from protocol and/or site expectations, and action items.
• Proactively identify, prevent, and mitigate program risks. Manage/resolve site and/or monitoring issues including appropriate retraining, issue escalation, and/or implementing corrective actions to prevent recurrence.
• Develop training materials and study tools for sites and CRAs use.
• • Performs other duties as assigned.
• Bachelor of Science degree required; Nursing degree is a plus.
• CCRA Certification preferred
• Minimum 7 years’ relevant experience in clinical research with at least 5 years monitoring and/or co-monitoring of clinical trials (Phase III and Oncology experience preferred).
• Vendor management experience is required.
• Extensive knowledge of trial oversight activities is required.
• Prior experience as a Lead CRA from a CRO and/or pharmaceutical company is preferred.
• Ability to plan, organize and prioritize own tasks in a fast paced and changing environment.
• Good oral and written communication skills.
• Ability to work independently as well with interdisciplinary teams (internal and external).
• Result and goal-oriented and committed to contributing to the overall success of Progenics.
• Ability to travel up to 20%-travel to investigator sites for Sponsor oversight or co-monitoring activities
• Ability to work onsite at Progenics headquarters.
Technical Skills Required:
• Possess highly effective interpersonal and organizational skills
• Strong experience with clinical study technologies, including electronic data capture (EDC), interactive response technology (IRT), electronic Trial Master File (eTMF), clinical trial management (CTMS) systems
• Strong proficiency with MS Office Suite
• Have strong written and verbal communication skills
• Strong understanding of clinical studies including critical elements of GCPs and federal regulations as it relates to clinical monitoring, IRB and Investigator responsibilities.
• Ability to multi-task and work effectively in a team or independently on assigned tasks.
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