1

applicant

Full-time Senior International Project Leader (m/f)

at Daiichi Sankyo in Munich

Key responsibilities:

Responsible for conducting interventional (phase IIIb, IV trials) and non-interventional studies (Registries, Post Authorization studies
Leadership of cross-functional international study teams
Matrix management of pan-European studies ensuring that all deliverables are met within the agreed timelines, budget and resource requirements
Supervision of the preparation, submission and follow-up of all relevant study documents to authorities/ regulatory bodies and Ethics Committees
Responsible for preparation of study protocols, eCRF, project plans, study reports, publications
Organisation and chairing investigator meetings and team meetings Management of study related Steering Committees
Act as an interface between DSE and Daiichi Sankyo Affiliates within Europe
Daily management of CROs and service providers
Development of clinical outsourcing specifications wit CROs and other 3rd parties
Contribution to the implementation of best practices and standards for study management, including sharing lessons learned
Training of internal CRAs regarding study requirements
Close collaboration with Medical Affairs assuring that study designs meet the global medical strategy
Representation of Clinical Operations in brand teams

Requirements:

University degree in medicine or natural sciences with a minimum of 5 years experience in the pharmaceutical industry or CROs, doctorate preferred
Minimum of 5 years experience in clinical research and international project management
Thorough knowledge of Clinical Research Principles, ICH –GCP , EU regulations governing clinical trials, standard regulatory and clinical practices and current regulatory issues related to clinical research
Thorough knowledge of project management tools and practices
Knowledge of pharmaceutical business and international drug development
Familiar with local regulations for non-interventional studies within EU
Fluent written and spoken English knowledge


Personal profile:

Demonstrate creativity and practice change management in order to guarantee a continuous improvement
Proven leadership skills in a matrix environment
Show empathy, respect and fairness
Live a culture of cooperation and team-work and take action to prevent and solve conflicts
Ability to work independently and as part of a team
Work proactively and encouraging others, show assertiveness
Strong communication, negotiation and presentation skills
Effective planning und review of projects
Analytical and systematic thinking, problem solving and ability to drive medical decisions


We offer:

You will be offered a challenging environment, where you will have the opportunity for personal growth. A comprehensive, attractive and competitive remuneration package will be discussed personally.

Please send us your CV and letter of interest using the online application option below.


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Published at 23-04-2012
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