Clinical Project Manager

Highly Competitive
  1. Permanent
  2. Project/Study Manager (CSM/CPM)
  3. Germany
Posting date: 10 May 2021

Proclinical has partnered with an established CRO who are looking for a Clinical Project Manager to join their growing team. They are running several phase II/III studies.

You will be responsible for overseeing studies where you will manage also manage vendors. There is a lot of opportunity to take on a range of responsibilities whilst working in an autonomous and driven environment.

This is a great opportunity to move into a truly global role and to join a company several high-profile studies ongoing.

Job Responsibilities

  • Coordinate and oversee project activities
  • Organise project activities and evaluate timeframes
  • Manage the administrative aspects of studies
  • Manage study materials (re-supply/drug expiration/re-labelling of drugs, various materials)
  • Prepare study specific procedures and tools (if applicable) - Prepare feasibility questionnaires (if applicable)
  • Manage the vendors involved in the study
  • Review and approve the Investigator's Folder and Trial Master File prototype
  • Verify compliance with operating procedures
  • Ensure that the monitoring activities are conducted as per monitoring plan requirements
  • Review monitoring, remote monitoring, contact and telephone contact reports
  • Send regular updates to the Sponsor
  • Ensure that the enrolment curve is on track and take actions in case of under-performance
  • Keep track of terminating studies and do the final check of the completeness of TMFs
  • Maintain contacts with clinical staff as necessary
  • Manage relationships with Data Centres
  • Perform co-monitoring visits with CRAs, if necessary
  • Coordinate/participate in Investigator's Meeting, Monitor's Meeting and project meetings
  • May act as Clinical Project Leader for international projects
  • Collaborate to on-boarding of new associates and act as a mentor of junior staff
  • Collaborate in establishing and maintaining SOPs related to Clinical Operations Unit

Skills and Requirements

  • University/college degree (life science or medical degree preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
  • Significant experience in project management of clinical trials (minimum 1 year of Project Management experience)
  • Previous or current CRO/sponsor experience or Medical Device Manufacturer experience
  • Broad knowledge of medical terminology, clinical patient management and clinical research
  • methodology
  • Advanced team leadership skills
  • Advanced decision-making skills
  • Demonstrates sound judgment in decision making process and has strong understanding of scope of contracts, including milestones and recognition of changes

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.