CLINICAL PROJECT MANAGER
Posted: 7/21/2010
Type: Contract
Length: 6 Months
Location: Cambridge, MA
Description
Our client is a growing pharmaceutical company that is looking for an experienced hands on Clinical Project Manager to join their Clinical Operations team. This CPM will be a hands on Project Manager overseeing several oncology studies in different phases. It is important that this resource have experience working directly with investigator sites, medical monitors, etc, and not just the management of outside vendors / cro's.
RESPONSIBILITIES:
• Manage clinical studies to ensure that they are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
• Manage study activities, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports
• Manage study sites and train clinical site staff to ensure protocol and regulatory compliance.
• Responsible for clinical site budget development
• Manage the activities of vendors, including clinical services, data management, biostatistical services, and central laboratory services
• May be responsible for ensuring SOP and regulatory compliance of staff
• Assists in the development and writing of study protocols, study plans, study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA). Interact with investigators and thought leaders for protocol development, presentations and publications.
• Coordinate and participate in investigator meetings.
• Estimate and manage the clinical supplies needed for the conduct of clinical trials
• Develop clinical monitoring plans and establish study monitoring priorities
• Address and seek resolution of administrative issues with investigational sites and/or CROs
Job Requirements
• Bachelor's degree in a relevant scientific discipline or equivalent.
• 5+ years of relevant clinical PM experience in the pharmaceutical industry
• Knowledge of GCP and ICH guidelines required.
• Proficiency in the implementation, monitoring, and management of Oncology clinical trials
• Demonstrated managerial and supervisory skills
• Proficiency with MS Word, Excel, Outlook, and PowerPoint. Microsoft Project skills preferred.
To apply, please contact:
Email: job@orbisdata.com
