Clinical Data Coordinator II

Clinical Data Coordinator II #clinicalresearch #clinicaltrials #clinicaldataanalyst #REGULATORYaffairs #medicalcoding #medicalbilling #research #healthcare #medicalresearch #clinicaltrial #science #clinical #health #clinicalstudies #pharma #medical #pharmacy #biotech #clinicareers #pharmacovigilance #pharmaceuticals #clinicalstudy #pharmacovigilance #medicalaffairs #clinicalresearchassociate #pharmaindustry #doctor #phd #oncology #drugdevelopment #cra #biotechnology # Job Specification Purpose: To action all tasks relating to Clinical Data Management from the start to the finish of a study. To support Project Manager in studies across DM functions. Core Accountabilities: Activities required of a Clinical Data Coordinator I however not restricted to are as below: To assist in the testing of databases prior to activation. To assist in the preparation of study specific documentation as appropriate. To assist with the processing of clinical data for projects. To critically review CRFs as specified in the Data Management Plan and to query any errors or omissions with either the study sponsor or the investigator as required. To track and resolve Data Clarification Forms in the study specific Database. To resolve SelfEvident QueriesAllowable Changes in the study specific Database. To perform the Quality Control of Data Entry and CRFdatabase as appropriate. To prepare any documentation for return to clientinternal archiving at study completion as requested. To be aware of and to work to the standards appropriate to the study CRO or customer. To advise on possible improvements to procedures and standards. To perform other reasonable tasks as requested by management. To perform other reasonable tasks as requested by management Qualifications: Education: Qualified to an appropriate standard, preferably to degree level in a life sciences subject. Skills, Knowledge, and Experience: 36 years of work experience in Clinical Data Management PC skills, including some knowledge of Excel and Word. Extensive knowledge of at least 1 Clinical Data Management systems such as Oracle Clinical, Medidata Rave, Inform. Excellent organizational skills and analytical skills and attention to detail. Good communication skills oral and written and good analytical skills. Basic knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing. Ability to manage competing priorities in a changeable environment. Ability to inspire effective teamwork and motivate staff.