Demo

Associate Project Manager

KlinEra Global Services Inc
San Jose, CA Full Time
POSTED ON 3/1/2025
AVAILABLE BEFORE 5/26/2025

Job Description :

The Associate Project Manager (APM) will support the project management team in the planning, execution, and monitoring of clinical trials. This role requires strong organizational skills, a keen attention to detail, and the ability to manage multiple tasks simultaneously. The APM will work closely with project managers, clinical teams, and external stakeholders to ensure trials are conducted on time, within budget, and in compliance with regulatory standards.

Key Responsibilities :

  • Assist in the development and execution of project plans, timelines, and budgets for clinical trials. Help ensure that milestones are achieved on time and within the allocated resources.
  • Communicate with internal teams, including clinical, regulatory, and data management departments, as well as external stakeholders such as sponsors, sites, and vendors.
  • Maintain accurate and up-to-date study documentation, including protocols, informed consent forms, and regulatory submissions.
  • Ensure compliance with internal SOPs, ICH / GCP, and local regulations.
  • Assist in tracking and managing clinical trial data, ensuring accuracy and completeness. Work closely with data managers to support data collection and cleaning activities.
  • Support the coordination and monitoring of clinical trial sites, ensuring that all site activities, including patient recruitment and retention, are progressing according to plan. Help identify and address project issues and challenges, escalating concerns to senior project managers when necessary.
  • Assist in generating study status reports, tracking project progress, and reporting on milestones to both internal teams and clients.
  • Help track project budgets, assist with invoicing, and ensure that the trial stays within financial constraints.
  • Provide administrative support to senior project managers, including scheduling meetings, preparing agendas, and documenting meeting minutes. Assist with team coordination and internal communication.
  • Ensure that the trial is conducted in compliance with regulatory guidelines (FDA, ICH / GCP), and help maintain study documentation for audits and inspections.
  • Assist in the onboarding and training of new team members, ensuring they are familiar with project-specific processes and standards.

Required Education / Experience :

  • Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field. Certification in Clinical Research (e.g., ACRP or SOCRA) is a plus. 1-3 years of experience in clinical research, with exposure to clinical trial management, clinical operations, or project support roles.
  • Preferred Skills :

  • Strong organizational and time-management skills with the ability to handle multiple tasks and priorities.
  • Excellent communication skills (verbal and written) to effectively interact with various stakeholders.
  • Attention to detail and ability to maintain accurate records.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is a plus.
  • Ability to work collaboratively within a team and support project managers in all aspects of clinical trial management.
  • Knowledge of ICH / GCP and regulatory requirements is a plus.
  • What We Offer :

  • Competitive salary and benefits package.
  • Opportunities for career development and growth.
  • Collaborative and supportive work environment with a focus on professional development.
  • Exposure to diverse therapeutic areas and advanced clinical research techniques.
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