(Associate) Clinical Project Manager

Reference Number: 895886-W
Type of placement: , Permanent

Introduction:

Support Clinical Operations to ensure clinical trials are completed on time, within budget and in compliance with the protocol, ICH/GCP and applicable regulatory requirements. Develops a basic understanding of the disease, molecule and indication whilst gaining experience in clinical trial management procedures. Maintains a high level of professionalism within the company and in interactions with external stakeholders.

Main Responsibilities:

  • Co-monitor at investigative sites to ensure protocol compliance, field monitor performance and appropriate study conduce.
  • Review of monitoring visit reports and track all items to resolution
  • Support and interact with CROs, vendors and study sites as needed to respond to issues
  • Assist in preparation of study specific documents, reports and materials as appropriate
  • Assist team as appropriate in the preparation of regulatory documents and submissions
  • Participates in the review of CRF and clinical database listings for completeness and accuracy
  • Participate in planning of investigator and other relevant meetings
  • Maintains Trial Master File
  • Coordinates and reviews regulatory documents from study sites: ensures completeness and accuracy
  • Responsible for tracking IND Safety Reports for assigned sites
  • Identify and escalate issues appropriately
  • Participate in clinical team(s), including attending required meetings and appropriately representing functional area
  • Partners with team members and other functional areas such as Regulatory, QA, Legal, Biometrics
  • Develops knowledge of the investigator contract, budget and payment process
  • Completes required corporate training on standards, policies and work instructions by the scheduled due by date
  • Flexibility necessary for travelling and working hours/working schedule
  • Perform other duties as assigned

Qualifications and Experience:

  • BS/BA degree in a life science or related field
  • Experience in pharmaceutical/biotech or clinical research environment as a CTA or equivalent
  • Previous monitoring experience preferred
  • Fluent English
  • Good verbal and written communication skills
  • Strong Interpersonal skills
  • Attention to detail
  • Good organizational and time management skills are necessary
  • Ability to work well in a team and independently
  • Working knowledge of ICH-GCP and relevant regulations
  • Proficiency in MS Word, Excel and Powerpoint

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