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Clinical Project Manager

Employer
KlinEra Global Services Inc
Location
San Jose, CA
Start date
Aug 22, 2024
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Job Details

Qualifications

  • Bachelor's degree in life science/related field, advanced degree preferred
  • Minimum of 5+ years in clinical research industry 
  • Proven experience as a clinical project manager or similar role in the pharmaceutical, biotechnology, or medical device industry
  • In-depth knowledge of clinical research, FDA regulations, and ICH/GCP guidelines
  • Strong leadership, organizational, and time management skills
  • Ability to manage multiple priorities and work effectively in a team environment

Responsibilities

  • Develop comprehensive project plans that outline project scope, objectives, timelines, resources, and budget requirements
  • Coordinate internal resources and third parties/vendors for flawless execution of projects
  • Ensure all projects are delivered on-time, within scope, and within budget
  • Identify and manage project risks and issues effectively
  • Implement risk mitigation strategies to minimize project risks
  • Ensure all project activities comply with relevant regulations and quality standards
  • Monitor and report on project progress to stakeholders
  • Lead and motivate project team members and influence them to take positive action and accountability for their assigned work
  • Facilitate effective communication and collaboration among project team members, stakeholders, and sponsors.
  • Manage stakeholder expectations and resolve any issues that arise
  • Prepare and maintain project documentation, such as project plans, status reports, meeting minutes, and correspondence
  • Provide regular updates to management and stakeholders on project progress

Company

Established in 2005, KlinEra provides innovative, customized clinical trial and research services to conduct ethical and efficient clinical trials that will accelerate the delivery of novel therapeutic treatments with faster patient access. As a global company, we have offices on every major continent, with our headquarters based in the heart of Silicon Valley. A significant asset is our 350 employees, reflecting our commitment to inclusivity and equity within the workplace.

KlinEra has extensive experience in a diverse number of therapeutic areas for the last two decades. A thorough understanding of specific therapeutic areas, including gastroenterology, oncology and neurology, ensures compliance and facilitates optimal delivery. Our unsurpassed network of key opinion leaders and established relationships with investigators enable expedited enrollment and quality results. To date, we've completed over 50 large-scale phase 1, 2 and 3 trials successfully by implementing complete clinical trial management, medical monitoring, data management and site management services, all utilizing high-quality protocols and Good Clinical Practices (GCP).

As a company, we strive to establish lasting values and principles, provide excellent working conditions, and give back to the community. Outside of primary business functions, KlinEra offers KlinEducate which contributes to educating the younger generation about the clinical research industry. KinEra also provides affordable medical care to over 1200 patients every month at a subsidized cost in India. KlinEra has always been committed to sustainable business practices, preserving its values, and helping the environment.

CONNECT

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Company info
Website
Phone
(408)791-0120
Location
313 Piercy Rd
San Jose
California
95138
United States

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