Client
The organisation in question is a global operation with affiliates in 26
countries and is seeking to expand its presence in Europe by means of
further internationalisation. They have production sites in seven countries
to supply the world market. They have a specialist knowledge base within the
pain/analgesics TAs as well as CNS and oncology.
Our client markets its products all over the world. At the same time they
in-license products in traditional indications and out-license their own
successful developments.
In 2004 they employed more than 1,800 people in Germany alone, and
altogether more than 4,800 people world-wide and their products are
available in more than 100 countries worldwide.
Role: Clinical Data Manager
In this position you will:
. Design Case Report Forms (CRFs), diaries and other data collection forms
. Creating and finalising the Data Management Plan
. Coding adverse events and diagnoses as specified in the study protocol
. Continuously monitoring data flow
. Ensuring that necessary tasks to achieve a clean database are performed
prior to database lock
. Appropriate filing and archiving essential documents
. Providing input into the selection and qualification of third party
vendors
. Assisting in preparing agreements with third party vendors and subsequent
tracking of all deliverables.
You are qualified for this position if:
. You have at least a bachelor's degree in Medical Documentation, Natural
Sciences or Informatics
. You have at least one year experience as a Clinical Data Manager
. You have a sound understanding of regulations and guidelines, e.g. ICH,
GCP, European Clinical Trials Directive, Privacy rules (HIPPA)
. You are fluent in English, basics in German is of advantage
. You show strong communication skills and enjoy working in international
and intercultural teams.
If you feel that this position is something you would like to proceed with,
please send me through a copy of your most recent CV and a contact number so
that we can set up a mutually agreeable time to discuss.
Kindest regards
Ash
Ash Butt LL.B Law (Hons) | Managing Director | AspirionPharma
Tel + 44 (0) 208 320 1085
Fax + 44 (0) 208 320 1087
Mobile + 44 (0) 783 529 6437
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