招聘人数:8-10人
到岗时间:不限
年龄要求:不限
性别要求:不限
婚况要求:不限
Location could be in Beijing Or Shanghai
PURPOSEManage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time an d within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership an d vision to the team in the areas of project planning, execution, an d close-out; financial management; communications; an d milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, and/or a leadership role in a specific CDM task (e.g. Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.RESPONSIBILITIES
Client Management:? Serve as primary point of contact for customer on data management deliverables? Provide project management expertise working with customer data managers, key decision makers, an d internal team members to manage continuous process improvements, issue escalation, workload projections, an d provide technical expertise? Provide justification for an d perform direct negotiations with customer, e.g., timelines, financial, process, resources? Maintain strong customer relationships? Ensure open communications with customer an d Quintiles management to manage an d meet contractual obligations
Service Management:? Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines an d quality deliverables? Establish strong communications with Data Operations team, functional leads, project managers an d all other stake holders? Support DM service delivery with comprehensive DM process an d technical expertise in executing projects? Serve as the escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolution? Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables? Create and/or review an d sign-off on all data management plan (DMP) documents? Ensure service an d quality meet agreed upon specifications per the DMP an d contract/SOW? Implement proactive quality management plans across multiple projects/programme. Track service performance an d provide leadership to identify root causes of issues an d implement remedial actions? Continuously look for opportunities to improve service; work with team to develop an d implement plan to re-organise an d drive change across multiple projects/programme (with minimal support)? Ensure timely follow-up an d resolution of compliance issues? Serve as Subject Matter Expert (SME)- Provide leadership an d expertise in a specific CDM task Or technology? Train an d mentor junior DTL staff in DM expertise. May coordinate the work of more junior DTL staff? Maintain internal tracking databases an d systems
Financial Management/Business Development Support:? Ensure service an d quality meet agreed upon timelines an d deliverables in contract/Scope of Work (SOW)? Manage SOW/budget- Review financial reports on a monthly basis an d participate in project reviews as requested- Identify out of scope tasks an d track change orders to completion? Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, an d invoicing?Participate in an d support RFP process (review RFP documents, pricing, attend bid defense)
Other:? Independently bring solutions to the CDM team/CDM department? Lead and/or participate in a focus team Or global Or local best practice team? Communicate lessons learned and/or present in CDM workshop(s)? Participate in the development an d implementation of new technology Or tool? Present at professional conferences and/or publish articles in professional journals? Provide review an d input on developing, revising, an d maintaining core operating procedures an d work instructions? Perform other duties as directed by the functional manager
REQUIRED KNOWLEDGE, SKILLS an d ABILITIES? Previous experience an d proven competence in managing delivery of multiple projects through full DM life-cycle (several studies/programmes)? Demonstrated expert data management skills an d thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology)? Previous experience of handling customer negotiations? Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology? Knowledge of operating procedures an d work instructions an d the ability to apply them in practice? Knowledge of Good Clinical Practices an d relevant regulatory guidelines? Excellent communication, interpersonal, customer service, an d teamwork skills? Excellent project management skills? Excellent organizational an d problem-solving skills? Ability to work independently with available resources, e.g., functional managers, senior DTLs? Comprehensive understanding of clinical drug development process? Ability to establish an d maintain effective working relationships with coworkers, managers an d customers
MINIMUM REQUIRED EDUCATION an d EXPERIENCE? Bachelor’s Degree, Or educational equivalent, in health, clinical, biological Or mathematical sciences, Or related field, an d a minimum of 5 years direct Data Management experience, including 3 Or more years as a CDM project lead; Or equivalent combination of education, training an d experience
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