Clinical Study Manager – Stockholm - Avslutad

We are looking for a Clinical Study Manager to a pharmaceutical company in the Stockholm 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 later phases of clinical development to manage the execution and delivery of a Phase III clinical study.

Main assignments

  • To manage execution and reporting of global clinical studies according to agreed time, 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, including identifying  change of scope
  • To coordinate and contribute to the compilation of critical study documents e.g., Protocols, Protocol Amendments, CRFs, Patient Information Documents and Reports  as required
  • To work with the Clinical Outsourcing Manager with management of delegated CRO Contracts and Amendments related to the study including identifying change of scope requirements
  • Drive the data cleaning and data base lock process through the CRO
  • 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 GCP 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 from conducting global clinical studies in phase III from the pharmaceutical/biotech industry (head quarter, subsidiary, and/or CRO)
  • Experience from the data cleaning and data base lock phase in a study
  • Experience from the report phase
  • Experience of managing external service providers
  • Documented project management skills 
  • Excellent command in English, written and spoken

Personal Competencies

  • Excellent written and oral communication abilities
  • Demonstrated ability to lead and motivate teams
  • Excellent problem solving skills, and proactive approach to study management
  • Strong individual initiative, drive, organization skill and multi-tasking abilities
  • Hands-on approach, with a high level of pro-activity, commitment and energy
  • A results-orientated person who sees the key issues within the whole picture and still the ability to focus on details.

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” 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. There is good possibilities that the project will be prolonged.

Aktivia Science Work AB is a consultant 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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