临床研究项目经理PM招聘_铂镁医学临床研究（上海）有限公司最新招聘信息-猎才医药网

临床研究项目经理PM 上海

铂镁医学临床研究（上海）有限公司

月薪： 1.5-2.5万/月

无工作经验
本科
招1人
11-09 发布

五险一金
交通补贴
餐饮补贴
年终奖金
专业培训

职位描述

职位描述： Description:Responsible for the overall direction, coordination, implementation, execution, control and completion of specific projects ensuring consistency with company strategy, commitments and goals.Responsibilities:1 Manages study sites (from site selection, startup and enrollment to close-out) to ensure compliance to protocol, ICH_GCP and applicable regulations.2 Supervises clinical research associates' training, effectiveness, and productivity.3 Identifies potential investigators for new studies and researches their qualifications using CVs, publications, and personal contacts.4 Supervises patient enrollment, study data review, and query resolutions efforts.5 Ensures the delivery of appropriate study-specific training to CRAs and sites.6 Provides day-to-day oversight of the clinical data review process during study conduct.7 Creates and utilizes study-specific questionnaires, study site materials, and other assessment tools for use in evaluation of study sites.8 Creates and maintains applicable project documents, including but not limited to Site Management Plans, Monitoring Guidelines, Site Operations Manuals and applicable templates, presentations and scripts.9 Supports investigators in fulfilling their obligations with regard to submission according to applicable local, regulatory, and IRB/IEC requirements.10 Reviews and approves monitoring reports and ensures tracking of ongoing site issues.11 Performs study tracking to ensure that the study files are current, accurate, and complete.12 Liaises with CRA regarding all site monitoring, data review, and query resolution issues providing guidance and suggestions for issue resolution.13 Manages clinical trials within the contractual timelines, deliverables and financial obligations.14 Direction of the technical, protocol-specific and operational aspects of assigned trials.15 Contributes to Business Development Activities by participating in proposal designs as required.16 Establishes close working relationships with the study sponsor through exceptional communication on a regular basis.17 Provides review and approval of invoices from study vendors, IRB approvals and informed consent documents, monitoring reports, clinical study agreements, etc.18 Participates in and conducts visits and meetings with investigative sites, physicians, sponsors, and consultants, as required.19 Is responsible for achieving study objectives by working with team members to set project priorities and milestones and resolve project conflicts.20 Responds promptly and appropriately to study issues raised by investigative sites, sponsors, monitors and consultants.21 Performs co-monitoring visits when necessary. Including TMF and ISF QC per SOP requirement.22 Develop plans to achieve contracted milestones (i.e. project plan, risk management plan, site management & monitoring plan, training plan, communication plan, etc.) .23 Participates in and conducts visits and meetings with investigative sites, physicians, sponsors, and consultants, as required.24 Conduct all activities according to the defined project-Specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements.25 Manage project budget and resource expenditures including invoicing, analyzing cost variances and conducting revenue recognition.26 Provides review and approval of invoices from study vendors, IRB approvals and informed consent documents, monitoring reports, clinical study agreements, etc.27 Accountable for CRO and vendor oversight and management.28 Experienced PM is accountable for coaching junior PM.Requirement：Minimum of six to seven (6-7) years relevant clinical research experience with at least three (3) years project management Experience in the pharmaceutical or CRO industries will be considered. Demonstrated skills and competency in clinical project management tasks.Competences / Skills:1 Organisational skills2 Analytical skills3 Well developed interpersonal skills4 Numeracy skills5 Commercial awareness6 Communication skills7 Team working skills8 Diplomacy9 Ability to motivate people10 Management and leadership skills11 Fluent English (oral and written) 职能类别：临床研究员