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Clinical Study Lead
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Client, Support, Network
Projektbeschreibung
Our client is a pharmaceutical company and is looking for a CLINICAL STUDY LEAD to take part to CLINICAL DEVELOPMENT ACTIVITIES related to one of their products. The CLINICAL STUDY LEAD will work at our client for at least 6 months.
The Clinical Study Lead:
- Participates in the CLINICAL DEVELOPMENT ACTIVITIES for a program or product/franchise in order to ensure the high quality and on-time delivery of clinical data that will allowworld-wide registration in compliance with the clinical development plan, good clinical practices(GCP), and standard operating procedures (SOP).
- Is a PHYSICIAN and will typically manage 7 to 10 clinical trials concurrently (within a large project or franchise), most of which are in Phase II to Phase IV; the total number of subjects enrolled at any time in trials under the incumbent's supervision will amount to approximately 5000; the number of Principal Investigators to manage will generally exceed 5.
- Will manage study budgets up to approximately 20 Mi annually.
- Will actively participate and occasionally be delegated to lead the multidisciplinary clinical project team for assigned studies (Biostatisticians, Central study coordinators, Scientific Writers and members of Data Management team) and provide advice and consultation to Clinical Development management for the assigned studies.
- Gains trust and support within the governing bodies and must lead and inspire the members of clinical project teams occasionally under great stress.
- Operates crossfunctionally to lead in a Matrix organization and must be able to build and sustain personal relationships with peers and subordinates to succeed
The Clinical Sutdy Lead is/has:
- MEDICAL DOCTORS ONLY (MD)
- Basic mastery of EPIDEMIOLOGICAL and statistical tools
- Good technical writing and teaching skills; good stage presence for public speaking
- Strong technical, statistical and computer skills and the ability to interpret complex clinical data and experimental results.
- Ability to develop network internally and externally to communicate in situations requiring special tact and diplomacy.
- Excellent oral and verbal communication skills
- Sound scientific background required to critically evaluate all scientific aspects of vaccinology/immunology
- Proven expertise in clinical research (at least 2 years) with international Good Clinical Practice Guidelines, basic knowledge of human experimentation laws and regulations.
The Clinical Study Lead:
- Participates in the CLINICAL DEVELOPMENT ACTIVITIES for a program or product/franchise in order to ensure the high quality and on-time delivery of clinical data that will allowworld-wide registration in compliance with the clinical development plan, good clinical practices(GCP), and standard operating procedures (SOP).
- Is a PHYSICIAN and will typically manage 7 to 10 clinical trials concurrently (within a large project or franchise), most of which are in Phase II to Phase IV; the total number of subjects enrolled at any time in trials under the incumbent's supervision will amount to approximately 5000; the number of Principal Investigators to manage will generally exceed 5.
- Will manage study budgets up to approximately 20 Mi annually.
- Will actively participate and occasionally be delegated to lead the multidisciplinary clinical project team for assigned studies (Biostatisticians, Central study coordinators, Scientific Writers and members of Data Management team) and provide advice and consultation to Clinical Development management for the assigned studies.
- Gains trust and support within the governing bodies and must lead and inspire the members of clinical project teams occasionally under great stress.
- Operates crossfunctionally to lead in a Matrix organization and must be able to build and sustain personal relationships with peers and subordinates to succeed
The Clinical Sutdy Lead is/has:
- MEDICAL DOCTORS ONLY (MD)
- Basic mastery of EPIDEMIOLOGICAL and statistical tools
- Good technical writing and teaching skills; good stage presence for public speaking
- Strong technical, statistical and computer skills and the ability to interpret complex clinical data and experimental results.
- Ability to develop network internally and externally to communicate in situations requiring special tact and diplomacy.
- Excellent oral and verbal communication skills
- Sound scientific background required to critically evaluate all scientific aspects of vaccinology/immunology
- Proven expertise in clinical research (at least 2 years) with international Good Clinical Practice Guidelines, basic knowledge of human experimentation laws and regulations.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges