Description
One of the world's most innovative pharmaceutical companies is looking to recruit a Senior Clinical Data Manager who will be able to provide specialized knowledge and detailed attention to carry out data management data review activities in support of one or more clinical research studies. This is a cotract to hire, on site opportunity based in the San Francisco Bay Area.Skills:
- Proven experience in the management of consultants and/or staff at an external vendor is essential.
- Proficient in the use of database management systems such as Oracle Clinical, ClinTrial, Medidata Rave or Oracle INFORM.
- Proficiency in the use of clinical data browsers (such as Hyperion Brio) essential
- Knowledge and familiarity with database theory, specifically relational database concepts.
- Good interpersonal skills.
- Good verbal and written communication skills.
- Experience with desktop tools.
- Ability to work on multiple tasks simultaneously and meet project deadlines.
- Demonstrated ability to interact confidently with members of other functional areas in study teams.
- Thorough understanding of regulatory guidelines (such as ICH guidelines E6)
- Competence in SAS Programming Language will be a positive advantage.
- Thorough understanding of the clinical trials process.
- Extensive previous experience of working in a pharmaceutical marketing environment with data from phase IV clinical trials is an advantage.
- Working knowledge of CDISC SDTM standard is a positive advantage.
- Participation in a regulatory filing, such as in the development of an e-submission or CTD will be a plus.
- Experience interacting with others for defining and implementing data listings / patient profiles
- Experience in working in teams and communicating one-on-one and with groups.
Education:
A minimum of 7-10 years of clinical data management experience in a pharmaceutical or biotechnology company or clinical research organization (CRO) essential, with a BS or higher in a bio-medical discipline (eg Biological Sciences, pharmacology etc). *Working in a fully outsourced model* very important.
To find out more about Real please visit www.realstaffing.com