Job descriptions & requirements
JOB SUMMARY
QualificationsBachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field5+ years direct Clinical Data Management experience in CRO or pharmaceuticals industry , including 3+ years as a CDM project lead; or equivalent combination of education, training and experiencePrevious experience and proven competence in managing delivery of multiple projects through full DM life-cycle (several studies/programmes)Previous experience of handling customer negotiationsKnowledge of Good Clinical Practices and relevant regulatory guidelinesExcellent communication, interpersonal, customer service, and teamwork skillsComprehensive understanding of clinical drug development processAbility to establish and maintain effective working relationships with co-workers, managers and customers
RESPONSIBILITIES
Client ManagementServe as primary point of contact for customer on clinical data management deliverablesProvide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertiseProvide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resourceMaintain strong customer relationshipsEnsure open communications with customer and Quintiles management to manage and meet contractual obligationsService ManagementMeet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverablesEstablish strong communications with Data Operations team, functional leads, project managers and all other stake holdersSupport DM service delivery with comprehensive DM process and technical expertise in executing projectsServe as the escalation point for unresolved data issues; work with client data managers, vendors, and internal team members for resolutionWork with functional manager(s) to ensure appropriate resources are assigned to meet project deliverablesCreate and/or review and sign-off on all data management plan (DMP) documentsImplement proactive quality management plans across multiple projects/programme. Track service performance and provide leadership to identify root causes of issues and implement remedial actionsServe as Subject Matter Expert (SME)Provide leadership and expertise in a specific CDM task or technologyMaintain internal tracking databases and systems
REQUIRED SKILLS
Research planning, Data analysis, Data collection, Documentation and record keeping, Reporting, Statistics
REQUIRED EDUCATION
Bachelor's degree
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