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SR Clinical Project Manager

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Company: Chesapeake Consulting

Location: Gaithersburg, MD

Date Posted: January 7, 2015

Source: Chesapeake Consulting

The Senior Clinical Project Manager (SCPM), serves as the primary contact for site investigators, study coordinators, as well as internal Novavax departments regarding issues associated with the daily operations of one (or more) clinical studies. Responsible for all aspects of one or more phase 1-4 clinical trials from protocol through clinical study report finalization for regulatory submission. Ensure compliance with ICH-GCP, FDA/ EMA, other regulations and SOPs, as applicable. Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards. Responsible for the management of CROs and ensure adherence to scope of work within timelines and budget. Manage interactions with other departments and relevant functional areas.
Responsibilities include but are not limited to:
* Management and implementation of clinical trial protocols consistent with clinical regulatory development plans
* Leads clinical study / project group to attain project goals and ensure compliance to scientific objectives
* Oversight of assigned clinical ...
The Senior Clinical Project Manager (SCPM), serves as the primary contact for site investigators, study coordinators, as well as internal Novavax departments regarding issues associated with the daily operations of one (or more) clinical studies. Responsible for all aspects of one or more phase 1-4 clinical trials from protocol through clinical study report finalization for regulatory submission. Ensure compliance with ICH-GCP, FDA/ EMA, other regulations and SOPs, as applicable. Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards. Responsible for the management of CROs and ensure adherence to scope of work within timelines and budget. Manage interactions with other departments and relevant functional areas.
Responsibilities include but are not limited to:
* Management and implementation of clinical trial protocols consistent with clinical regulatory development plans
* Leads clinical study / project group to attain project goals and ensure compliance to scientific objectives
* Oversight of assigned clinical projects in regards to status, timelines, budget and resources
* Responsible for the development, management and tracking of trial budget working closely with the Vice President, Clinical Operations.
* Responsible for oversight and preparation of recommendations for the selection and the management of project CROs, central labs, and other clinical trial vendors in the delivery of contracted services.
* Provided input and contributes to RFP preparation, proposal review, budget negotiation and contract development;
* Provides input and contributes to the development of protocols, Investigator Brochures, and related documents, in the scientific review of clinical data, and in trial data analysis, reporting and publishing.
* Responsible for oversight of the development of study-related documents such as informed consent, case report forms, etc.
* Participate as necessary in monitoring visits (co-monitoring), reviews monitoring visit reports and ensures CRO quality within trials
* Proactively escalates project related issues to the Vice President, Clinical Operations to ensure timely resolution of issues.
* Responsible for the delivery of Quality Assurance and quality control of clinical data of the assigned studies / projects
* Contributes to Quality Assurance activities, i.e. assists in development and updating of SOPs
* Contributes to knowledge management within Clinical Operations
* Plans, executes, and leads Investigators´ Meetings, if applicable
* Assists in the planning of Data (Safety) Monitoring Boards
Minimum Requirements:
* BS/BA degree or equivalent (background in life sciences preferred). Advanced degree is preferred.
* 6 + yrs of industry experience (biotech/pharma) with at least 4 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 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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