External Data Specialist – Contract

🔥 2 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $85k - $110k / year

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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eClinical Solutions

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2012

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

💰 Private Equity Round on 2020-01

Consulting • Healthcare • Biotechnology

eClinical Solutions is a clinical data management company that provides integrated data review and management solutions for the biotech and pharmaceutical industries. Their platform, elluminate, empowers organizations to modernize and automate their clinical data workflows, ensuring efficient data acquisition, management, and analysis. By leveraging advanced analytics and technology-driven approaches, eClinical Solutions helps streamline trial operations and improve productivity, enabling better decision-making in clinical research.

📋 Description

• Process external and/or local lab data throughout the clinical trial lifecycle • Follow departmental SOPs, guidelines and global standards to maintain data integrity and consistency • Assist the Clinical Data Management team with local lab and external data documentation review and quality control • Communicate data point and validation issues to Clinical Data Managers, study teams and management • Perform QC and data entry for laboratory normal ranges • Review study protocols and eCRF designs and recommend approaches for data aggregation and capture • Ensure clinical databases align with external vendor data requirements • Perform QC of external data test transfers for acceptance • Maintain external data reconciliation and change logs • Verify normal ranges are linked to patient results • Review vendor and laboratory data in elluminate and issue queries or communicate data issues • Provide input to DMP, IDROP and CCG documentation • Perform study start-up, build and IST activities • Develop and QC exception listing specifications and visualizations • Support external vendor data transfer agreements • Provide study-specific data metrics to Clinical Data Management, clients and Project Management • Attend internal and external study team calls as needed • Collaborate cross-functionally on study reporting and data trending to identify and mitigate risks • Support Manager, External Data with Lab Admin team mentoring • Perform other assigned duties

🎯 Requirements

• Basic Science/Bachelor of Science degree in a health-related field or an equivalent combination of education, training and directly related experience preferred • Medical Laboratory Technology certificate preferred • Excellent command of the English language, written and verbal • Understanding of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology • Basic understanding of medical terminology • Ability to maintain confidentiality of data and information • Ability to work independently and manage multiple projects • Detail oriented, able to multitask, with strong organizational skills • Strong communication skills • Knowledge of clinical data management processes and vendor data processing • Excellent team player and collaborator

🏖️ Benefits

• Remote work • Professional development and career growth opportunities • Work-life balance • Inclusive, people-first culture • Equal opportunity employment • Top Workplaces USA recognition for Remote Work