美国新泽西招聘临床统计总监和数据管理副总监
工作地piscataway，NJ
美国当地是新筹建团队，汇报给高级总监
属于临床CRO公司
1. Director of Statistics
Responsibilities
1.Lead the statistical group to complete projects in a timely and quality manner.
2.Provide statistical inputs/consultants on trial design, protocol and CRF development, perform sample size calculation, interact with clients with regard to statistical issues
3.Authoring and review of statistical analysis plans and statistical methodology sections in clinical protocols in different therapeutic areas from phase I to phase IV
4.Manage team activities including training and mentoring, issues resolving, quality control and timely completion of project deliverables, ensure on-time deliver best value and high-quality service
5.Develop, review and improve standard operation procedures (SOPs), working instructions (WIs), standard templates and procedures to ensure all activities in accordance with internal and external quality standards, SOPs/WIs, ICH-GCP and/or any other applicable local and international regulations, guidelines and industry standards and improve productivity and efficiency of the team
6.Maintain a positive, collaborative, results orientated work environment, build partnerships and teamwork, communicate to team in an open, transparent and objective manner
7.Manage team activities including training and mentoring, issues resolving, quality control and timely completion of project deliverables, ensure on-time deliver best value and high-quality service.
Qualification
1.MS or PhD in Statistics, Biostatistics or related field. PhD with 8+ years or MS with 10+ years of pharmaceutical or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.
2.Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations.
3.Demonstrated ability to identify areas of statistical research in improving the design, analysis and reporting of clinical study.
Associate Director of Data Management
Responsibilities
1.Responsible for ensuring the completeness, quality and integrity of the Clinical Trial data.
2.Ensure data quality and consistency according to applicable regulatory requirements, SOPs, Processes and data standards.
3.Ensure all data management activities to be compliance with GCP, relevant regulatory requirements and SOP/WI (work instructions) of company and/or Sponsor.
4.Ensure following and applying CDISC or applicable standard through Clinical Trail.
5.Ensure acknowledge, follow and to be consistent with company Policies and procedures.
6.Study management responsibilities but not limited to:
Act as Lead Data Manager for one or more clinical trials, arrange resource, and assess their workload.
Identify work scope and study timeline for study setup or close-out.
Participate internal/external functional meetings.
Oversee review all responding data management task status of clinical trials.
Project monitor and ensure trail deliverables to meet the expected timelines and quality.
Participate in internal/external audits and regulatory inspections.
Communicate effectively and appropriately with internal & external team including vendors and clients.
Risk management on any data quality deliverables.
Assist study quotation of data management activities.
Mentor and train other team members, including but not limited to all levels of Clinical Data Coordinators and Lead Data Managers.
Ability to build and manage data management staff.
Can fulfill and guide all responsibilities for lower level.
7.Lead clinical data management project teams in the delivery of services to clients to ensure project team be consistent with Client needs, expectations and contractual obligations.
8.Ensure staff fulfill their responsibilities in accordance with company policies, procedures, SOPs, ICH-GCPs, and other relevant regulatory requirements.
9.Create clinical data management SOPs, processes; identify and implement process improvements through review of clinical data management SOPs, processes.
10.Build teamwork and improve process and productivity by working within and across functional areas.
11.Participate in business development initiatives, including presentations and proposal development, ensure that timely and accurate information is submitted on all proposal efforts.
Qualification
1.Bachelor Degrees or above in life/medical science, mathematics or related field.
2.At least 10 years’ experience within a data management role, understanding of process including study management, vendor management, CRF design, database set-up, edit check specification, DMPs and data cleaning activities.
3.2+ years of staff management experience.
4.Extensive knowledge of FDA, GCP and other regulations' requirements of clinical trials.
5.Extensive knowledge of clinical trials.
6.Strong oral and written communication, and knowledge of medical terms.
7.Timeline adherence, reliability, efficiency, attention to details, quality driven.