91 applicants

Company

eClinical Solutions · 6 hours ago

Senior External Data Specialist

United States

Full-time

Remote

Senior Level

5+ years exp

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H1B Sponsor Likely

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Responsibilities

Act as primary study contact, subject matter expert (SME) and liaison for external data and local lab processing on assigned studies for internal and external stakeholders

Communicate to Clinical Data Manager, study team, and/or Manager, External Data problems involving local lab data point issues and validation issues

Communicate to vendors and client issues involving external data transfers, 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 data transfer agreement set-up logs, 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

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 QC the output for movement to production

Drive the set-up and implementation of external vendor data transfer agreements and specifications, working closely with the client, vendors, and functional teams

Provide study specific local lab and/or external vendor data driven metrics to Clinical Data Management, Client and/or Project Management

Report client and/or study level local lab and/or external vendor data driven units to Project Management for scope monitoring

Attend internal and external study team calls, as needed, for support of study specific local lab and external vendor data processes

Identify and recommend process improvements, working with functional team leads and management for developing, reviewing, and implementing processes and guidelines for external data and local lab data processing

Support management for reporting of external data and local lab KPI’s and performance metrics

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

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

ICH/GCP guidelines21 CFR Part 11Clinical trial methodologyClinical data managementScienceMedical Laboratory TechnologyVendor data processingExternal data typesCRO experienceEnglish language proficiencyMedical terminology

Required

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

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 multiple projects

Detail oriented, ability to multitask, with strong organizational skills

Strong communication skills

Knowledge of clinical data management processes and vendor data processing

Familiarity with various 3rd party vendors and data transfers

Understands a variety of external data types and methodologies

Strong leadership and mentoring skills

Considerable experience within the CRO or pharmaceutical industry

Preferred

Medical Laboratory Technology certificate

5+ years’ experience or an equivalent combination of education and experience to successfully perform the key responsibilities of the job

Company

eClinical Solutions

eClinical Solutions is a data intelligence hub.it transforms the way clinical data integration, aggregation, and analytics.

Founded in 2006

Mansfield, Massachusetts, USA

201-500 employees

http://www.eclinicalsol.com

H1B Sponsorship

eClinical Solutions has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (8)

2022 (6)

2021 (5)