Associate/Clinical Project Manager (CPM)

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Full Time
Posted 2 weeks ago

Associate/Clinical Project Manager (CPM)

Reports to: Head of Project Management & GxP System Application

Why you’re here

To ensure completion of high-quality clinical trials on time and within budget and be the interface with the Sponsor to ensure good communication and relationships with different stakeholders.

What you’ll deliver

  • Clinical trial projects delivered on time, with quality standards and within budget
  • Efficient and effective study start-up process through closeout activities
  • On-time delivery of all clinical trial milestones

 How we’ll measure it

  • Up to date and well maintained internal files and documents
  • Quality of relationships with internal and external stakeholders
  • Milestone delivery of trial portfolio

What you’re responsible for

  • Ensuring all aspects of a clinical trial, including patient recruitment, data collection and documentation, are conducted professionally and to a high-quality standard, in accordance with GLC’s policies and procedures and ICH GCP
  • Overseeing and managing clinical trials including all aspects of clinical monitoring, investigator/site selection, site budget negotiations and preparation of study essential documents
  • Studying vendor management including contract negotiations, coordination of activities and timely delivery as per study timelines
  • Ensuring all clinical management systems (e.g. CTMS and eTMF) and other applicable systems, are in place, accurate and consistently maintained
  • Planning, implementing and managing subject recruitment plan and retention strategies
  • Preparing and conducting on-site qualification, study initiation, monitoring and close-out visits, as necessary
  • Escalating issues to client and GLC management when required to ensure swift resolution
  • Organising and actively participating in Investigator Meetings, client meetings, project team meetings and project-specific training
  • Planning and conducting country-level feasibilities as requested
  • Contributing to coaching, mentoring and developing staff in order to meet the GLC studies expectations for productivity, quality and goal achievement. Complete mentoring and co-monitoring visits with junior, or new, clinical team members as required

Qualifications

  • Life Sciences degree or equivalent combination of education, training and relevant industry experience

Work experience

  • Strong experience in the project management of complex and/or global trials with a Pharmaceutical, CRO, biotechnology and medical device background.
  • Strong experience conducting clinical trials in accordance with GCP methodology

Technical knowledge & skills or other requirements

  • Deep understanding and comprehensive practical knowledge of ICH-GCP requirements & international Regulatory Authority Regulations
  • Able to work in an international environment with internal & external team partners (including virtual teams)
  • Highly collaborative with good stakeholder management skills
  • Strategic thinking and analytical skills
  • Strong organisational and planning skills
  • Excellent verbal and written communication skills
  • Attention to detail and ability to work simultaneously on multiple priorities
  • Self-starter with the ability to adapt and be flexible to changing priorities
  • Ability to travel required

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