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Clinical Trial Manager

New Jersey All, NJ

Posted: 01/28/2019 Job Type: Clinical Job Number: JN -012019-23518
Responsible for supporting the Senior Clinical Trial Manager/operational study lead, and 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:

Supports the Sr. CTM/operational study lead in collaborating 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
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
Supports the Sr. CTM 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:
Bachelor s degree
Minimum of 3 to 5 years of trial management experience in the pharmaceutical industry/CRO with emphasis on Phase II-IV clinical trials
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
Program and project management experience
International experience a plus

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) background
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
Must possess demonstrated skill in the following:
Change Management
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
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