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Sr Clinical Data Manager
Eingestellt von Real Staffing Group aus Frankfurt am Main
Gesuchte Skills: Design, Client
Projektbeschreibung
Responsibilities:
- Working within clinical study teams as an extended team member
- Executing the clinical data management operations against project timelines, and any other priorities
- Using defined department metrics as a framework for timely and quality clinical data management deliverables
- Collaborating with peers within and outside the GDO organization to pro-actively manage data availability and integration
- Acting as a Lead Data Manager for less complex studies, and as determined by ability and proficiency level in essentials skills
- The employee is expected to be Skilled of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
- The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all company policies, and procedures. Company policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Qualifications:
- Degree or equivalent experience in Clinical Research, Computer Science, Project Management or related field: 6 years experience, or BS/BA degree with 4 years experience, or MS degree with 2 years experience
- Minimum 2 years experience within a clinical data management organization, preferably within medium-large pharma or CRO
Intermediate knowledge and understanding of regulatory guidelines for the use of computer systems in clinical trials
- Intermediate knowledge of Research & Development and an understanding of regulatory guidelines/requirements related to R & D (e.g., ICH, GCP, safety reporting)
- Intermediate knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.)
- Ability to travel 5%
This is a fantastic opportunity to work for a large Pharma client on a long term contract.
If you meet the criteria please apply immediately to be considered for an interview.
Key words: clinical data management, CRO,Pharma,California,OrangeCounty
To find out more about Real Staffing please visit www.realstaffing.com
Projektdetails
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Einsatzort:
Irvine, California, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Medien/Design