Clinical Trial Manager

 
Location: Madison, New Jersey
Posted On: 10/3/2017
Job Code: CTM_NJ_3255
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Job Description
 
Position Details:
Client : Pharmaceutical
Location : Madison, NJ 07940
Job Title : Clinical Trial Manager
Duration : 06 Months (Possibilities of Extension - Full time contract)

Responsibilities:
• As the operational study lead, serves as the primary representative of Clinical Operations to Clinical Affairs and other functions supporting the execution and delivery of an assigned study(s) (e.g. Clinical Planning, Regulatory Affairs, Global Drug Safety, Pharmaceutical R&D, R&D Quality Assurance)
• Supports the Clinical Program Manager by providing study status updates, and informs and as needed escalates issues; Provides operational support as needed at various meeting interactions with, as example, advisors or Partners
• Accountable for the execution and adherence to integrated study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders inclusive of all operational accountabilities, including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as FRI’s SOPs and policies.
• Accountable for accurate and timely entry of study information (e.g. design, results) into ClinicalTrials.Gov in collaboration with RAs and Clinical Affairs
• Accountable for monitoring study operational plan, and managing operational study budget, timelines, and risk mitigation processes with input from key stakeholders
• Accountable for direct supervision and mentoring of Clinical Trial Managers
• Accountable for oversight of Clinical Trial Manager activities
• In collaboration with key stakeholders, responsible for supporting 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.
• Accountable for the management and maintenance of the study TMF
• Accountable for leading, and managing the process for the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with the study team, CRO Management, Clinical Affairs and key stakeholders

Education:
B.S. degree; Advanced degree (e.g. Master, PharmD, PhD) preferred

Experience:
• Minimum of 5 years of pharmaceuticals/biotech experience
• Minimum of 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials
• Extensive experience in the operational and scientific/medical aspects of clinical development.
• Critical thinking skills, and ability to identify potential issues and solutions, across clinical development programs.
• Strong project management, leadership and mediation skills within a matrix environment.
• Continuous improvement experience preferred.
• Ability to work across broad range of interfaces, and take broad perspective to harmonize processes and procedures.
• Demonstrated ability to develop and manage end to end study operational plan
• Demonstrated ability to operationally execute and deliver a quality clinical trial
• Proven leadership abilities and demonstrated experience directly working in multidisciplinary study teams
• Demonstrated ability to execute within a matrix management model, ideally in pharmaceuticals/biotech
• Timeline, budget and resource management experience required
• Demonstrated experience in change management initiatives preferred
• Program and project management experience preferred
• International experience a plus
Category:Non-IT  code:new
 
 
Job Requirements
 
 
Cloud Computing, Training, Direct3D, Research, Change Management, Quality Assurance, Project Management, Management, Quality Control
 

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Contact Details
 
Recruiter
Vishnu Krishnan
 
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