Clinical Study Manager - Sobi
Aktivia Science Work is looking for a Clinical Study Manager to the Sobi HQ in Stockholm, Sweden.
Clinical Program Management is a part of Clinical Development and has the overall responsibility to lead, manage and deliver clinical programs for development projects as well as marketed products. Clinical Program Development ensure that a clinical program strategy is developed and implemented in accordance with the overall therapeutic area strategy, project/product goals and regulatory requirements.
To secure an effective utilization of internal and external resources, a large part of clinical study activities are executed by External Service Providers (ESPs).
The Clinical Study Manager (CSM) leads and manages the cross-functional global clinical study team, and ensures delivery of all clinical study activities to agreed timelines, budget and quality. The CSM coordinates, contributes to and ensures delivery of key clinical study documents such as study protocols, protocol amendments, case report forms, patient information documents and clinical study reports as well as project management plans (e.g., communication, quality and risk management plans). The CSM defines the scope for ESPs, lead and manage appointed ESPs, and follow-up on ESP performance. The CSM forecasts and manages resources, budget and timelines for individual clinical studies and ensures that all clinical study activities and deliverables are compliant with Sobi SOPs, ICH/GCP guidelines and regulatory requirements.
- University degree in Life/Health Sciences
- A minimum of 5 years’ experience of planning, conducting and reporting multicenter, international clinical studies
- Extensive knowledge of all aspects of the clinical study process
- Experience of managing ESPs
- Demonstrated ability to lead multi-disciplinary teams including team building, negotiation and conflict resolution
- Excellent written and oral communication skills in English
- Collaborative, Accountable, Respectful and Engaged (Sobi CARE values)
- A high level of proactivity, commitment and energy
- Ability to work independently
- Excellent problem solving skills
- Strong individual initiative, organizational skills, and multi-tasking abilities
- A flexible and “can do” attitude
This position is a full time permanent position at Aktivia Science Work with full time placement and all reporting at Sobi.
Application and more information
Please call Knut Natt och Dag on +46 722 166 800 if you have any questions. Apply by e-mailing your CV and a personal letter to email@example.com as soon as possible. We are working continuously with this recruitment project. Write "CSM Sobi" in the subject field. We plan to have interviews for this position between January 9th and January 12th, 2018. Read about Aktivia Science Work on our website – www.aktivia.se
Welcome with your application.
Sobi is an international specialty healthcare company dedicated to rare diseases. Sobi’s mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primary focused on Haemophilia, Inflammation and Genetic diseases. Sobi also market a portfolio of specialty and rare disease products across Europe, the Middle East, North Africa and Russia for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2016, Sobi had total revenues of SEK 5.2 billion (USD 608 M) and approximately 760 employees. The share (STO:SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.