Clinical Trial Manager

1 week ago

Madison, New Jersey, United States PSG Global Solutions Careers Full time

Apply now and our proprietary system will quickly have you in front of a live recruiter.
The Opportunity
Description
We're looking for a Clinical Trial Manager, working in Pharmaceuticals and Medical Products industry in 5 Giralda Farms, Madison, New Jersey, 07940, United States.

  • Supports the Sr. CTM/operational study lead in collaborating with clinical affairs and other functions.
  • 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 FRIs SOPs and policies.
  • Responsible for managing assigned aspects of the operational study budget, timelines, and risk mitigation
    processes with input from key stakeholders.
Our Client

Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.

Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.

Experience Required for Your Success
  • Bachelors degree
  • 3-5 years of pharmaceuticals/biotech experience
  • 3-5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research 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, 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
  • 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 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
  • 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
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?

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