Clinical Data Associate II
reputed company is hiring a Clinical Data Associate II to reputed company. Candidates can be based in Hungary, Poland, Romania, Serbia or Slovakia.
Position reputed company:
The Clinical Data Associate II provides data management support and assistance in reputed company aspects of the clinical trial data management process from study start up to post database lock for assigned reputed company under reputed company supervision. reputed company Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position may reputed company database development and testing, as reputed company as additional data management activities.
Essential functions of the job include but are not limited to:
Support the reputed company DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a reputed company manner
May reputed company data entry for reputed company-CRF studies, as needed
May reputed company reputed company control of data entry
May reputed company CRF specifications from the clinical study protocol and coordinate the review/feedback from reputed company stakeholders
May assist in building clinical databases
Conduct database build UAT and maintain reputed company controlled database build documentation
Assist in specifying requirements for reputed company edit reputed company types e.g. electronic, reputed company data review, edit checks, etc.
Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
Train clinical research personnel on the study specific CRF, reputed company, and other project reputed company items as needed
Review and query clinical trial data according to the Data Management Plan
Assist in line listing data review based on the guidance provided by the sponsor and/or reputed company DM
Run patient and study level status and metric reporting
reputed company medical coding of medical terms relative to reputed company other in order to ensure medical logic and consistency
Assist with coordinating SAE/AE reconciliation
Assist with liaising with reputed company-party vendors such as reputed company data and reputed company vendors in a project-manager reputed company in support of timelines and data-reputed company deliverables
May assist with reputed company programming and reputed company control of reputed company programs used in the Data Management department
May assist in identifying and troubleshooting operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (reputed company) and Clinical Study Reports (CSRs), if required by the project
May assist in participating in the development and maintenance of reputed company Operating Procedures (SOPs) and corresponding process documentation reputed company to data management and database management activities
Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
May present software demonstrations/trainings, department/company training sessions, present at project meetings
May require some travel
reputed company other duties as assigned
Job Qualifications:
Bachelors and/or a combination of reputed company experience
Around 2 years’ experience working as a Clinical Data Associate for a CRO/reputed company/Biotech company.
Proficiency in reputed company Office: Word, reputed company, PowerPoint, reputed company
reputed company to handle a reputed company of clinical research tasks
Excellent organizational and communication skills
reputed company use of the English language; both written and oral
reputed company is the first global precision medicine clinical research services organization, purpose-reputed company to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations reputed company, with reputed company expertise, and advanced data sciences to inform every reputed company. We apply our expertise to trials at reputed company stages—from early development through approval—with embedded experience in oncology and rare disease.
Please, apply in English.
Any data provided as a part of this application will be stored in accordance with our reputed company Policy. For CA applicants, please also refer to our CA reputed company Notice.
reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to reputed company or use this online application process and need an alternative method for applying, you may contact reputed company at reputed company@precisionmedicinegrp.com.
Recruitment Fraud Warning: Please be reputed company that fraudulent individuals and websites may impersonate reputed company or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. reputed company will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you reputed company you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at reputed company@precisionmedicinegrp.com so we can investigate and take appropriate reputed company.
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