Description
Requirements: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
To find out more about Real Staffing please visit www.realstaffing.com