External Data Specialist (Contract)

eclinicalsolutions; Deutschland; Remote; EUR 52.000 - 72.000; Vollzeit

Zusammenfassung

eClinical Solutions in Germany is seeking an External Data Specialist to support processing of external and local lab data across the clinical trial lifecycle. You will ensure SOP adherence and data integrity while assisting the Clinical Data Management team.

Responsibilities include QC of laboratory ranges, reviewing local lab and external data eCRF design, maintaining reconciliation logs, and coordinating data transfer with external vendors. Excellent English and teamwork are essential.

Qualifikationen

• Bachelor of Science degree in health-related field or equivalent.
• Medical Laboratory Technology certificate preferred.
• Excellent command of the English language (written and verbal).
• Ability to maintain confidentiality of data and information.
• Understanding of ICH/GCP guidelines and clinical trial methodology.

Aufgaben

• Process external and local lab data per SOPs and global standards.
• Perform QC of laboratory ranges and review eCRF design for data aggregation.
• Maintain external data reconciliation logs and change logs.
• Coordinate data transfers with external vendors and study teams.
• Provide data-driven insights to support study reporting and analytics.

Kenntnisse

English language proficiency

Confidentiality

Independent work

Team player

Ausbildung

Bachelor of Science degree in health-related field

Medical Laboratory Technology certificate

Jobbeschreibung

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.

eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate , throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions.

You will make an impact:

The External Data Specialist is responsible for the processing of external and/or local lab data received at eClinical Solutions throughout the clinical trial lifecycle. The External Data Specialist works to ensure departmental SOPs, guidelines and global standards are followed to maintain data integrity and ensure consistency across all assigned projects. The External Data Specialist will assist the Clinical Data Management team with local lab and/or external data documentation review and quality control for trial deliverables .

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.

Your day to day:

In addition to the duties outlined, performs additional duties and responsibilities based on developing skills and capabilities:

• Communicate to Clinical Data Manager, study team, and/or Manager, External Data problems involving local lab and/or vendor data point issues and validation issues
• Perform QC of laboratory normal ranges prior to entry to ensure documents received are ICH/CGP compliant and accurate
• Perform Lab Normal Range data entry and/or QC, meeting processing deliverables on time and with quality
• Review study protocols and local lab and external data eCRF design in start-up, providing recommendations and insights into best approach for data aggregation and capture
• Ensure clinical database supports data requirements and is in alignment with external vendor data
• Perform QC of external data test transfers for acceptance
• Maintain external data reconciliation logs and/or change logs
• Verify the normal ranges are properly linked to the patient results in the local lab data collection module of the database
• Review external vendor data and/or local laboratory data listings via elluminate and issue queries or communicate data issues to internal and/or external team members
• Review and provide input to DMP, IDROP and CCG to ensure local lab normal range and/or external data process for assigned study is accurately documented
• Review study protocols and local lab and external data eCRF design in start-up, providing recommendations and insights into best approach for data aggregation and capture
• Ensure clinical database supports data requirements and is in alignment with external vendor data
• Perform local lab and external vendor associated study start-up and build activities
• Perform IST activities for local lab normal range population
• Develop the local lab and external data exception listing specifications and associated visualizations, and QC the output for movement to production
• Provide support for set-up and implementation of external vendor data transfer agreements
• Provide study specific local lab and/or external vendor data driven metrics to Clinical Data Management, Client and/or Project Management
• Attend internal and external study team calls, as needed, for support of study specific local lab and external vendor data processes
• Work closely with cross-functional teams on study reporting and data trending via clinical data analytics technologies for local laboratory and/or external vendor data to proactively identify and mitigate risks
• Support Manager, External Data with Lab Admin team mentoring
• Other duties as assigned

Take the first step towards your dream career. Here is what we are looking for in this role.

Qualifications:

• Basic Science/Bachelor of Science degree in health-related field or an equivalent combination of education, training and directly related experience to successfully perform the key responsibilities of the job preferred
• Medical Laboratory Technology certificate preferred
• Excellent command of the English language (both written and verbal)
• Ability to maintain confidentiality of data and information during interactions with staff at all levels
• Understanding of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Basic understanding of medical terminology
• Excellent team player and collaborator
• Ability to work independently and manage mult