北京招聘

• Conducts clinical pharmacokinetic (PK) and pharmacodynamic (PD) data analysis according to GCP and appropriate protocol, PKAP, SOPs, as responsible pharmacokineticist.
• Conducts non-clinical pharmacokinetic (PK) and toxicokinetic (TK) data analysis according to GLP and appropriate protocol, SOPs, as contributing scientist or principal investigator.
• Ensures mechanisms are in place to maintain flow of appropriate information between disciplines on project teams.
• Responsible to draft protocols, pk analysis plan (PKAP) and amendments, using proposal outline or client-supplied information, to include methodology, definition of derived variables and data-handling rules.
• Communicates and interacts with study team, other departments and clients as applicable.
• Assists in the development and maintenance of standard report/table formats as needed.
• Plans, prioritizes and manages own workload and multiple responsibilities.
• Independently use project tracking systems as appropriate.
• Learns to improve processes to increase the efficiency of daily/routine procedures and reporting methods.
• Responsible for report preparation, including table and figure preparation.
• Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence as applicable.
• Reviews QAU report audits. Submits audit responses for approval as appropriate. Follows up with appropriate personnel to ensure that all necessary report/raw data clarifications are completed within specified timelines.
• Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed.
• Responsible for report production processes through finalization, including archival of data as appropriate.
• Performs independent peer reviews of PK and PD deliverables (e.g. protocols, PKAP, PK reports) and raw PK analysis data record.
• Provides input and participates in project meetings, plans, monitors and guides project work.
• Trains, mentors, and assists less experienced staff.
• Participates in client visits as needed, assists in communicating technical information.
• Participates in process improvement initiatives.
• Effectively plans and utilizes personnel and resources for timely completion of assigned projects.
• Maintains an awareness of the financial status of ongoing studies
• Performs other related duties as assigned.

                                                                                            

    

Education / Qualifications

    

• Minimum Bachelor of Science/Arts (BS/BA) degree with 4-6 years working experience

        

    

Experience

• Experience may be substituted for education.
• Efficient use of word processing software, database, spreadsheet and specialized software
• Proficient in concise writing. Writing should require little or no external review or edit.
• Adherence to grammar, punctuation, composition and spelling accordingly to company standard conventions.
• Experience on a variety of studies performed in the department and exposure to a diverse client base.
• Knowledge of regulatory agency guidance.
• Proven ability to participate in and assist Study Director/Principal Investigators with pre-initiation and other study related meetings as required.
• Proven ability to manage increasingly complex projects and study designs and/or increased study load.
• Demonstrated capability to manage work for key clients.
• Demonstrated ability to support and be involved in process improvement initiates and endeavors
• Proven ability to plan, prioritize and manage workload and multiple responsibilities.

                                                

Key Words: 临床药理  PK/PD数据分析  WinNonlin系统

Location: 上海浦东新区张江伽利略路338号（免费班车）

LabCorp是全球顶尖的生命科学公司，科文斯作为LabCorp旗下的药物研发部门，肩负着改善人类健康与生命的共同使命。科文斯的实验室和设施遍布全球，在世界范围内拥有超过26000名员工，卓越的研发能力和强大的人才资源奠定科文斯在医药研发行业的领先地位。截止到2020年，科文斯中国团队共参与了近100个获得上市许可的新药研发，积极支持超过50个免疫肿瘤药物的研发项目，是服务***面的药物研发公司。

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