PM/CRA

面议

上海市

刷新时间：2024-04-15

职位描述

   Job Description:
a) Plans and executes study level project management activities for assigned studies including
study level timelines, risk assessment, mitigation plans, and other aspects of study level
project management (e.g. budget, metrics).
b) Develop and get alignment with internal senior management team and cross-function team
and external partners on milestone dates and tracks overall timeline to ensure delivery
throughout the whole study.
c) Closely monitor the status of ongoing projects. Identifies potential issues, risks in a timely
manner that may affect the critical path of the clinical study and project milestones.
including vendor selection, site selection, study start up, patient enrollment, date base lock,
site closure, study inspection. etc.d) Ensures quality compliance at the study level to achieve study /country /site level compliance,
as appropriate. Ensure appropriate regulatory requirement, GCP/SOP compliance.
e) Work as the key point of contact between internal and external clinical research partner at
the study level, maintain relationships with different cooperation partners.
f) Oversight the performance of 3rd party venders, including but not limited to
CRO/SMO/central lab/central imaging/PRO ects throughout whole study.
g) Dynamically reviews study team resource, provides timely actions in order to keep reliable
staffing resource strategy.
h) Develops/provides/supports study related training to study team, as appropriate.
i) Obtains clinical study cost forecasts. Establishes and monitors the study budget.
j) Maintains and archives at study level documentation.
k) Other appropriate responsibilities assigned by line manager.
Qualifications:
1) Bachelor's degree in a scientific or health care related field, e.g clinical medicine, nursing,
biological Sciences etc.
2) Comprehensive understanding of Good Clinical Practices, Good Documentation Practices,
FDA/NMPA regulations.
3) Excellent interpersonal skills and demonstrated business acumen with an ability to interface
successfully with internal and external cross-functional teams and individuals.
4) Excellent verbal and written communication skills. Good at oral and writing English.
5) Excellent office computer skills, including experience with clinical databases.
6) Effective cross-functional team player with ability to work in a team environment.
7) Demonstrated leadership skills and strong result driving.
8) Excellent project management and organizational skills; able to handle multiple tasks/projects
and manage priorities; with a high tolerance for ambiguity.
9) Experienced in serving on product development teams and understands the product
development lifecycle.    

   Job Description:
a) Perform site selection (if applicable), initiation, monitoring and close-out visits in
accordance with contracted scope of work and good clinical practice.
b) If applicable, may be accountable for supporting development of project subject
recruitment plan on a per site basis. Work with sites to adapt, drive and track subject
recruitment plan in line with project needs to enhance predictability.
c) Provide monitoring visits and site management for a variety of protocols, sites and
therapeutic areas.
d) Administer protocol and related study training to assigned sites and establish regular lines
of communication with sites to manage ongoing project expectations and issues.e) Evaluate the quality and integrity of study site practices related to the proper conduct of
the protocol and adherence to applicable regulations. Escalate quality issues as
appropriate.
f) Manage the progress of assigned studies by tracking regulatory submissions and
approvals, recruitment and enrollment, case report form (CRF) completion and
submission, and data query generation and resolution. May support start-up phase.
g) Create and maintain appropriate documentation regarding site management, monitoring
visit findings and action plans by submitting regular visit reports, generating follow-up
letters and other required study documentation.
h) Build awareness of features and opportunities of study to site.
i) Collaborate and liaise with study team members for project execution support as
appropriate.
Qualifications:
1) Bachelor's degree in a health care or other scientific discipline or educational equivalent
and 2 years related working experience; or equivalent combination of education, training
and experience.
2) Good knowledge of, and skill in applying, applicable clinical research regulatory
requirements; i.e., Good Clinical Practice (GCP) and International Conference on
Harmonization (ICH) guidelines.
3) Strong therapeutic and protocol knowledge as provided in company training.
4) Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and
use of a laptop computer.
5) Strong written and verbal communication skills including good command of English
language.
6) Strong organizational and problem-solving skills.
7) Effective time management skills.
8) Ability to establish and maintain effective working relationships with coworkers, managers
and clients.   

其他要求

招聘人数：1人
职能类别：临床监查员CRA

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。