Clinical Study Manager – Lund - Avslutad

We are looking for a Clinical Study Manager to a pharmaceutical company in the Lund area. The team where the position belongs is responsible for the planning, execution and delivery of Clinical Development Programs and for the management of individual Clinical Trials.

You need to have experience in managing studies in early phases – late phases of clinical development. You will be responsible for the execution and delivery of First-In-Human clinical studies to late phase studies and will be working together with the clinical team and the Director, Clinical Programme Management, in the planning of clinical development programs.

Main responsibilities

  • To lead and manage all aspects of clinical studies according to the clinical development plan and agreed timelines, cost and quality
  • To follow-up study deliverables and ensure appropriate contingency plans are in place 
  • To manage the contact of identified areas of responsibility between the CRO and the client company and follow up on CRO performance
  • To coordinate and contribute to the compilation of critical study documents e.g., Clinical Study Protocols, Protocol Amendments, CRFs, Patient Information Documents and Clinical Study Reports as required
  • To coordinate the clinical activities with respect to Investigational Medical Product (IMP) e.g., ordering, labeling, extension of expiry date
  • To work with the Director, Clinical Programme Management, with management of delegated CRO Contracts and Amendments related to the study including identifying change of scope requirements
  • Organizing and maintaining tracking systems and tools to support the study
  • Pre-approve payments, follow-up costs for clinical study activities and track performance of external service providers
  • Document management and administration
    • To ensure maintenance, completeness and archiving of the Study Master File
    • To ensure all clinical activities are conducted according to SOPs, ICH/GCP guidelines and regulatory requirements

Requirements

  • University degree in Life/Health Sciences
  • A thorough knowledge of all aspects of the clinical study process
  • A minimum of 5 years experience of conducting early phase – late phase clinical studies from the pharmaceutical/biotech industry (head quarter) and preferably at least 5 years experience from conducting clinical studies in all phases of development (head quarter, subsidiary and/or CRO)
  • Experience of clinical study protocol and clinical study report writing
  • Experience of managing external service providers
  • Documented project management skills 
  • Excellent command in English, written and spoken

You are welcome to call Mr Knut Natt och Dag on 0722 166 800 or Mr Rolf Mayer on 0708 87 60 05 if you have any questions concerning this position. Send your application with your CV and a short personal letter to job@aktivia.se as soon as possible due to our on-going work with this recruitment. Write “Clinical Study Manager Lund” in the subject field.

You will be employed by Aktivia Science Work AB and will work as a consultant in our client company. The employment is full time for 12 months.

Aktivia Science Work AB is a consultancy and recruitment company within Life Science specialized in positions within the pharmaceutical industry. We have offices in Stockholm and in Lund and are part of Karolinska Institute Science Park in Stockholm and the Life Science centre in Lund. We are members in SwedenBIO and Medicon Valley Alliance. You can read more about us on our website, www.aktivia.se.

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