Clinical Project Manager
Title: Clinical Project Manager
Location: Central New Jersey – Local candidates only
Base Compensation: $100,000 - $130,000
Managing clinical projects including overseeing site monitors, site initiation activities, clinical vendor management, and other duties as required.
• Development of overall program plans
• Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Management of third-party contractors (CROs) which will perform site monitoring activities.
• Assisting the Regulatory Department in preparing submission packages;
• Leading team meetings vendor management tracking study progress and outsourced activities.
• Prepare and present project information at internal and external meetings.
• Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.
• Lead problem solving and resolution efforts to include management of risk, contingencies and issues.
• Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
Bachelor's degree in life sciences or related field and 5 years of clinical research experience including 2 years of project management experience and experience in clinical operations; or equivalent combination of education, training and experience.
Experience managing third party vendors (CROs)
PMP certification preferred.
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines to US and Canadian standards
Experience directing and influencing a team.
Life Cycle Drug Development experience for Clinical Operations.
Excellent communication skills strong financial planning budgeting risk analysis and forecasting skills.
MS Project Excel PowerPoint Outlook etc. fluency.
Must be a team player.