Global Pharmaceutical company is expanding in new offices in Madison, NJ
This Clinical Trial Manager is an essential part of the Clinical Operations team.
Looking for a strong Clinical Trials Professional with a operation experience for phase 2, 3 and 4 trials.
Multiple therapeutic reas.
-responsible for the delivery of studies , responsible for the execution and adherence of various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as FRI’s SOPs and policies.
-Will oversee monitoring assigned aspects of the study operational plan and managing assigned aspects of the operational study budget, timelines, and risk mitigation
Input on the development and application of standardized operational study processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness.
This Manager will manage and oversee the study TMF as well as assist in site selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with the study team and key stakeholders.
Bachelors degree and Minimum of 3 to 5 years of pharmaceuticals/biotech experience.
-Phase II-IV clinical trials.
-Process and system thinking, customer orientation, and ability to work in multidisciplinary study teams and to execute within a matrix management model, ideally in pharmaceuticals/biotech.
-Experience in execution of clinical research trials, including GCP and regulatory guideline knowledge and audit inspections.
-Knowledge and experience in clinical study budgeting including timeline and the application of clinical trial performance metrics.
-Demonstrated ability to support the development and management of various aspects of the end to end study operational plan.
-Demonstrated ability to support the operational execution and delivery of various aspects of a quality clinical trial.
-Demonstrated experience in change management initiatives preferred.
-Program and project management experience preferred.
( in addition: Knowledge of drug development and FDA GCP/ICH regulatory guidelines. Proficiency with and ability to utilize software applications that support Clinical Operations: Microsoft Word, Excel, PowerPoint; Adobe Acrobat, EDC systems, etc. Clinical trial management system (CTMS) background is a plus. Strong ability to work within a matrixed organization, managing multiple tasks in a timely, budget conscious manner. Ability to identify and work with key stakeholders to deliver operational requirements. Ability to consistently operationalize abstract ideas.
Decision-making, Judgment, and Problem Solving
Interpersonal relationships, team building, motivating, mentoring associates and Influencing
Initiative and Accountability, Promoting Innovation and Process Improvement
Strong oral and written communication skills. Ability to embrace change and comfortable with ambiguity.