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Clinical Operations Expert Support/COES 14-001
Eingestellt von Michael Bailey Associates - Munich
Gesuchte Skills: Support
Projektbeschreibung
CLINICAL OPERATION EXPERT SUPPORT
BASEL/SCHWEIZ
7.7. - 31.12.2014
JOB PURPOSE
Responsible for supporting, under the leadership of the Clinical Trial Head or Global Trial Leader (CTH or GTL), all aspects of clinical trial(s) (Phase II through life cycle management) and program level activities as assigned.
RESPONSIBILITIES
1. Support CTH/GTL in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Assigned responsibilities can include development of specific sections of protocol and related documents; development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
2. Support CTH/GTL in preparation of clinical outsourcing specifications and in the follow-up with day to day operational activities with the Contract Research Organization(s) (CROs).
3. Support CTH/GTL in managing interactions with Global Clinical Development Operations and other relevant functions including Drug Supply Management and local medical organizations.
4. Update regularly all trial information databases and tracking systems in order to manage accuracy of information.
5. Contribute to the ongoing scientific review of the clinical trial data during the course of the trial.
6. Support CTH/GTL in delegated aspects of trial data analysis and reporting.
7. May assist in program level activities (eg, tracking of CD basic knowledge of scientific principles.
Frank Arnold
Recruitment ConsultantMichael Bailey International is acting as an Employment Business in relation to this vacancy.
BASEL/SCHWEIZ
7.7. - 31.12.2014
JOB PURPOSE
Responsible for supporting, under the leadership of the Clinical Trial Head or Global Trial Leader (CTH or GTL), all aspects of clinical trial(s) (Phase II through life cycle management) and program level activities as assigned.
RESPONSIBILITIES
1. Support CTH/GTL in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Assigned responsibilities can include development of specific sections of protocol and related documents; development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
2. Support CTH/GTL in preparation of clinical outsourcing specifications and in the follow-up with day to day operational activities with the Contract Research Organization(s) (CROs).
3. Support CTH/GTL in managing interactions with Global Clinical Development Operations and other relevant functions including Drug Supply Management and local medical organizations.
4. Update regularly all trial information databases and tracking systems in order to manage accuracy of information.
5. Contribute to the ongoing scientific review of the clinical trial data during the course of the trial.
6. Support CTH/GTL in delegated aspects of trial data analysis and reporting.
7. May assist in program level activities (eg, tracking of CD basic knowledge of scientific principles.
Frank Arnold
Recruitment ConsultantMichael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges