will provide all aspects of Business Objects development and support to the usersPerform system changes/testingConverse with a range of users from beginners to experienced report developers Profund experience
/testingConverse with a range of users from beginners to experienced report developersProfund experience working with Business ObjectsDetailed knowledge of Business Objects version 4.2Experienced in report creation
PURPOSE Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures
aligned to current industry expectationsComplete study sample analysis and draft the bioanalytical report in support of urgent project requestsRepresent the bioanalytical function on project teams and
of company clinical work to determine marketability of productsEvaluate results of phase II - III investigations, in preparation for new drug application to the regulatory agenciesMonitor and reports
necessaryContribute to writing of Protocol and Core Informed Consent Form (CICF), including amendmentsInput into the Clinical Study Report (CSR)Medical training of the Clinical Trial Team (CTT) members and/or Actelion
aligned to current industry expectationsComplete study sample analysis and draft the bioanalytical report in support of urgent project requestsRepresent the bioanalytical function on project teams and
) Responsible for signal detection and management activities including, including respective documentation and drug safety reports Contributing to risk management activities including preparation and maintenance
Informed Consent Form (CICF), including amendmentsInput into the Clinical Study Report (CSR)Medical training of the Clinical Trial Team (CTT) members and/or Actelion staff Medical oversight of the study
of productsEvaluate results of phase II - III investigations, in preparation for new drug application to the regulatory agenciesMonitor and reports findings to senior managementReview and submits
, perform, interpret and report results of analytical experiments for the preparation and timely delivery of chemical drug substances (DS, small molecules)Manage all lab activities needed for the cGMP
expectationsComplete study sample analysis and draft the bioanalytical report in support of urgent project requestsRepresent the bioanalytical function on project teams and present results, data interpretation
required reports are generated and available for real time tracking of project statusResponsible for contracts with external service providers/vendors/academic units including review and approval
management activities including, including respective documentation and drug safety reports Contributing to risk management activities including preparation and maintenance of CCDS, labeling document