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Scientific. Clinical. Software Engineering


New Jersey All, NJ

Job Type: Clinical Job Number: JN -042020-26658 Region: New Jersey All

Job Description

Responsible for managing various aspects of the operational execution and delivery of quality studies, including in process quality control activities (e.g. quality checks and balances to ensure Inspection Readiness, Enrollment, Metrics, Milestones, Timelines and Budget)

Primary responsibilities of this position include:

Collaborate with clinical affairs and other functions, and responsible for, the execution and delivery of studies (e.g. Clinical Planning, Regulatory Affairs, Global Drug Safety, Pharmaceutical R&D, R&D Quality Assurance)

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 SOPs and policies

Responsible for monitoring assigned aspects of the study operational plan

Responsible for managing assigned aspects of the operational study budget, timelines, and risk mitigation processes with input from key stakeholders

Supports 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

Responsible for supporting the management and maintenance of the study TMF

Participates in managing the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with the study team and key stakeholders

Education and Experience:

B.S. degree

Minimum of 3 to 5 years of Clinical Trial Management pharmaceuticals/biotech experience with emphasis on 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, 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

International experience

Knowledge, Skills and Abilities:

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) experience

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

Ability to identify issues, analyze situations and provide effective solutions

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