Lead CRA - Lund

Vacancy information

Publication date:January 22 2021
Employment type: Permanent
Sector: Pharmaceutical
Function Group: Clinical Research

Function Group: Clinical Research / CRA

Organization

For a rapidly growing clinical research organisation in the pharmaceutical industry with a European focus, we are looking for a Lead CRA to join the local office in Lund, Sweden. The organisation has a flat hierarchy and allows you to implement your own way of working in your daily tasks. Since the organisation works solely for external clients, no day is the same, therefore being open to flexibility in this ever-changing organisation is an absolute must.

Function

As the Lead CRA, you will be responsible for monitoring activities of trials across several sites and/or countries, including proactive site management and oversight. Additionally, you will also be responsible for the following tasks:

  • Performing feasibility and assessing suitability of clinical trial sites
  • Participate in the risk-based quality management (RBQM) process with a focus on the monitoring strategy
  • Development and review of informed consent forms
  • Applications to ethics committee and review of regulatory submission packages as applicable
  • Review and approval of regulatory green light (RGL-packages)
  • Development of study-specific plans in collaboration with PM and sponsor
  • Review and approval of monitoring reports from other CRAs
  • Ensure adherence to agreed monitoring visit schedule across all sites
  • Oversight of SDV status, data entry status, and data quality standards across sites. Initiate root cause analysis, if not on track, and escalate to PM
  • Coordinate data cleaning activities in collaboration with data management
  • Plan and lead CRA-meetings to ensure knowledge sharing and common monitoring practice/implementation of study-specific processes across sites
  • Training and supervision of CRAs in trial-specific processes and procedures and co-monitoring visits
  • Day-to-day management of central lab as applicable

Requirements

In order to succeed in this challenge, we are looking for someone with the following requirements:

  • B.Sc. in the life sciences field or related discipline
  • A minimum of 3 years in a similar position in the pharmaceutical industry/biotech/CRO
  • Knowledge of GCP-guidelines, applicable regulatory requirements, medical terminology, and clinical trial processes
  • Willingness to travel
  • Excellent communication skills (written and verbal) in Swedish as well as English
  • Experience with multi-country and multi-centre trials preferred
  • Ability to translate client’s need into solid deliveries
  • Ability to work independently without supervision of a colleague within the group
  • Ability to supervise and coach non-senior personnel within the group

Offer

The organisation can offer you the following:

  • To work within different therapeutic areas and with tasks of varying complexity
  • A truly dynamic and ever-changing workday
  • To work with a heterogenous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia, and more)
  • To build international client-relations
  • To use and elaborate your competences and experiences
  • To work in an interactive, flexible, and positive working-environment

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Hans Dijkstra
Managing Partner

+45 89 88 26 70
h.dijkstra@qtcrecruitment.com

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