位于广州市天河区的 7 个优质data lead职位（正在招聘！）

FSP CRA(Guangzhou and Southern cities)
Fortrea —广州市
- 全职
Mechanical Engineer Job
Arkema B.V. —广州市
SENIOR SOFTWARE ENGINEER
HSBC Global Services Limited —广州市
- 全职
10 小时
FSP CRA II(Guangzhou/Fuzhou/Xiamen/Nanning)
Fortrea —广州市
- 全职
Senior AI Engineer
Standard Chartered —广州市
1天
FSP CRA II
Fortrea —广州市
- 全职
Sales Specialist
ABB (China) Ltd. Guangzhou Branch —广州市
快速申请

More jobs to discover

Find similar jobs that you might be interested in.

Mechanical Engineer Job
Arkema B.V. —广州市
Monitor and manage mechanical spare parts inventory; lead or participate in equipment failure RCA and share REX within the organization.
车辆认证工程师 Project Engineer
TÜV Rheinland —广州市
Education: Engineering Degree (preferably mechanical engineering or automotive specialization); Study and familiar with vehicle related worldwide motorcycle…

Show more similar jobs

我想收到关于广州市天河区的 data lead 的最新职位提醒

一旦登录您的账户，即表明您同意 SimplyHired 的服务条款和我们的Cookie 协议及隐私政策。

查看更多地区的职位

data lead jobs near 广州市天河区

位于广州市的Mechanical Engineer职位

位于成都市的Clinical Research Associate职位

位于上海市的Research Consultant职位

位于西安市的Associate职位

位于天津市津南区的Research职位

位于北京市朝阳区的Field Engineer职位

位于上海市的Staff Engineer职位

位于深圳市的Lead Associate职位

位于上海市的Junior Associate职位

位于苏州市的Ai Developer职位

位于上海市的Ai Agent职位

位于上海市的Data Integration Specialist职位

位于武汉市硚口区的Sales Manager职位

位于上海市的Tax Associate职位

位于深圳市的Client Associate职位

位于上海市的Data Engineer职位

位于上海市浦东新区的Staff Engineer职位

FSP CRA(Guangzhou and Southern cities)

Fortrea -
广州市

立即申请

职位详情

全职

完整职位描述

This role is for upcoming future opportunities that may arise at Fortrea

Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer

Summary of Responsibilities:

Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
Prepares and implements project plans related to Clinical Monitoring responsibilities.
Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
Ensures adherence to global quality control and CRA performance metrics.
Ensures audit readiness at site level.
Acts in the project role of a Lead CRA as assigned.
General On-Site Monitoring Responsibilities:
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data.
Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required.
Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
Travel, including air travel, may be required and is an essential function of the job.
Prepare and submit accurate and timely trip reports.
Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management.
Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management.
Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems.
Track IP shipments and supplies, as needed.
Track and follow-up on serious adverse events as assigned.
Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met.
Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.
Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed.
Present training content for site initiation.
Assist with training of new employees (e.g., co-monitoring).
All other duties as needed or assigned.

Qualifications (Minimum Required):

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
Thorough knowledge of monitoring procedures.
Basic understanding of the clinical trial process.
Fluent in local office language and in English, both written and verbal.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

External Candidates:
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND
A minimum of 2 years of Clinical Monitoring experience.
Internal Candidates:
Internal candidates with a minimum of 2 years of Clinical Monitoring experience.
Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.
Ability to work with minimal supervision.
Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
Good planning, organization, and problem-solving abilities.
Works efficiently and effectively in a matrix environment.

Preferred Qualifications Include:

Thorough working knowledge of Fortrea SOPs for site monitoring.
One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
Phase I monitoring experience.
Life Science or Nursing qualification.
Specific skills, systems, certifications, and/or licenses preferred.
Personal characteristics (leadership, problem solving, interpersonal skills).
Good attention to detail.
Methodical approach to work.
Good understanding of medical and clinical research terminology and clinical research processes.
An understanding of the basics of physiology, pharmacology, and medical devices (when applicable).
Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements.
Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English.
Focus on Customer.
Innovate and Change.
Pursue Scientific and Process Excellence.
Work with Others.
Achieve Results.
Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.
Demonstrated ability to conduct clinical operations activities most effectively and efficiently.
Good analytical and negotiation skills.
Experience using e-clinical systems [e.g., clinical trial management system (CTMS)].
For medical device positions, experience in providing customer service to device end users.

Physical Demands/Work Environment:

Must be able to sit at a computer for long periods of time.
Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day.
Standard office and/or home working environment.
Clinical Research Unit and hospital environment (administrative only).
Risk of eye strain.
Will involve outside of normal office hours as required by the role.
Travel Requirement is 60% of the time (traveling to study sites).

Learn more about our EEO & Accommodations request here .

立即申请

完善您的搜索

在广州市天河区的data lead个职位

FSP CRA(Guangzhou and Southern cities)

Mechanical Engineer Job

SENIOR SOFTWARE ENGINEER

FSP CRA II(Guangzhou/Fuzhou/Xiamen/Nanning)

Senior AI Engineer

FSP CRA II

Sales Specialist

More jobs to discover

我想收到关于广州市天河区的 data lead 的最新职位提醒

查看更多地区的职位

求职者工具

雇主工具

浏览

保持联系

完善您的搜索

在广州市 天河区的data lead个职位

Mechanical Engineer Job

SENIOR SOFTWARE ENGINEER

FSP CRA II(Guangzhou/Fuzhou/Xiamen/Nanning)

Senior AI Engineer

FSP CRA II

Sales Specialist

More jobs to discover

我想收到关于 广州市 天河区 的 data lead 的最新职位提醒

查看更多地区的职位

在广州市天河区的data lead个职位

我想收到关于广州市天河区的 data lead 的最新职位提醒