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Experience Level
Experience
Qualifications
We are seeking candidates with a background in clinical data management. Essential qualifications include:A strong attention to detail and organizational skills.Effective communication abilities, both verbal and written.Proficient in data entry and management software.Experience with clinical trial processes preferred.Ability to work collaboratively within a team environment.
About the job
Join Precision for Medicine as a Clinical Data Associate II and become a vital part of our clinical trial data management team. This role is open for candidates located in Hungary, Poland, Romania, Serbia, or Slovakia.
Position Overview:
The Clinical Data Associate II plays a crucial role in providing comprehensive data management support throughout the clinical trial lifecycle, from study initiation to post-database lock for assigned projects, all under direct supervision. You will adhere to Standard Operating Procedures (SOPs), regulatory directives, and study-specific plans and guidelines, while also assisting in database development and testing alongside various data management activities.
Key Responsibilities:
Assist the Lead Data Manager (DM) by ensuring task continuity and timely completion of responsibilities.
Perform data entry for paper CRF studies as required.
Conduct quality control checks on data entries.
Develop Case Report Form (CRF) specifications based on clinical study protocols and coordinate reviews with stakeholders.
Support the creation and maintenance of clinical databases.
Conduct user acceptance testing (UAT) for database builds, ensuring quality control of documentation.
Specify requirements for various edit checks including electronic and manual data reviews.
Create, revise, and maintain data management documentation.
Train clinical research staff on study-specific CRF, Electronic Data Capture (EDC), and other project-related materials.
Review and query clinical trial data according to the Data Management Plan.
Assist with line listing data reviews as guided by the sponsor and/or Lead DM.
Compile and run patient and study-level status and metric reports.
Engage in medical coding to ensure logical consistency of medical terms.
Support the reconciliation of Serious Adverse Events (SAE) and Adverse Events (AE).
Coordinate with third-party vendors, managing timelines and data deliverables.
Possibly assist with SAS programming and quality control of SAS programs within the Data Management department.
Help identify and troubleshoot operational challenges based on metrics data and audit reports.
About Precision for Medicine
Precision for Medicine is a leading provider of specialized services to the life sciences industry. We focus on helping our clients bring new therapies to market faster and with greater efficiency. By leveraging our expertise in clinical trials, regulatory compliance, and data management, we are dedicated to advancing healthcare outcomes.
Clicking Apply Now takes you to AutoApply where you can tailor your resume and apply.
Unlock Your Potential
Generate Job-Optimized Resume
One Click And Our AI Optimizes Your Resume to Match The Job Description.
Is Your Resume Optimized For This Role?
Find Out If You're Highlighting The Right Skills And Fix What's Missing
Experience Level
Experience
Qualifications
We are seeking candidates with a background in clinical data management. Essential qualifications include:A strong attention to detail and organizational skills.Effective communication abilities, both verbal and written.Proficient in data entry and management software.Experience with clinical trial processes preferred.Ability to work collaboratively within a team environment.
About the job
Join Precision for Medicine as a Clinical Data Associate II and become a vital part of our clinical trial data management team. This role is open for candidates located in Hungary, Poland, Romania, Serbia, or Slovakia.
Position Overview:
The Clinical Data Associate II plays a crucial role in providing comprehensive data management support throughout the clinical trial lifecycle, from study initiation to post-database lock for assigned projects, all under direct supervision. You will adhere to Standard Operating Procedures (SOPs), regulatory directives, and study-specific plans and guidelines, while also assisting in database development and testing alongside various data management activities.
Key Responsibilities:
Assist the Lead Data Manager (DM) by ensuring task continuity and timely completion of responsibilities.
Perform data entry for paper CRF studies as required.
Conduct quality control checks on data entries.
Develop Case Report Form (CRF) specifications based on clinical study protocols and coordinate reviews with stakeholders.
Support the creation and maintenance of clinical databases.
Conduct user acceptance testing (UAT) for database builds, ensuring quality control of documentation.
Specify requirements for various edit checks including electronic and manual data reviews.
Create, revise, and maintain data management documentation.
Train clinical research staff on study-specific CRF, Electronic Data Capture (EDC), and other project-related materials.
Review and query clinical trial data according to the Data Management Plan.
Assist with line listing data reviews as guided by the sponsor and/or Lead DM.
Compile and run patient and study-level status and metric reports.
Engage in medical coding to ensure logical consistency of medical terms.
Support the reconciliation of Serious Adverse Events (SAE) and Adverse Events (AE).
Coordinate with third-party vendors, managing timelines and data deliverables.
Possibly assist with SAS programming and quality control of SAS programs within the Data Management department.
Help identify and troubleshoot operational challenges based on metrics data and audit reports.
About Precision for Medicine
Precision for Medicine is a leading provider of specialized services to the life sciences industry. We focus on helping our clients bring new therapies to market faster and with greater efficiency. By leveraging our expertise in clinical trials, regulatory compliance, and data management, we are dedicated to advancing healthcare outcomes.