Clinical Data Manager I

Clinical Data Manager I #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 # Overview: We have an exiting opportunity for Clinical Data Manager I to lead, coordinate and action all tasks relating to Clinical Data Management from the start to the finish of a study and to project manage studies across DM functions. Responsibilities: Core Accountabilities Activities required of a Clinical Data Manager I however not restricted to are as below: Project management for allocated projects: To help plan and manage study timelines and resources. To manage progress against schedules and report to management. To perform project management across all functions for a study as appropriate. Management of CRFs and all related tasks. To contribute to the efficient running of the Clinical Data Management department as part of the Clinical Data Management leadership team. To proactively keep abreast of current data management developments and systems. To mentor data management staff To assist in the creation and review of inhouse SOPs. To research and provide input into inhouse strategies and systems. To perform other reasonable tasks as requested by management. RoleSpecific Duties: Ensure launch, delivery, and completion of all Data Management procedures according to contractual agreement and relevant SOPs, guidelines and regulations. Ensure consistency of process and quality across projects. Be willing to travel both domestically and internationally as necessary. To undertake other ad hoc tasks as required. Qualifications: Education Qualified to an appropriate standard, preferably to degree level in a life sciences subject. Skills, Knowledge, and Experience: 47 years of work experience in Clinical Data Management Extensive knowledge of at least 2 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. Thorough knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing. PC skills, including some knowledge of Excel and Word. Ability to manage competing priorities in a changeable environment. Ability to effectively lead project teams across multiple locations. Excellent project management skills. Ability to inspire effective teamwork and motivate staff. Ability to present at departmental and external client meetings.