Fortrea
EDS Portfolio Lead
Fortrea, Durham, North Carolina, United States, 27703
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.The
EDS Portfolio Lead
will support the Data Manager (LDM) with the review, maintenance, and update of external vendor data received from central vendor or local laboratories. Working to ensure company SOPs (or sponsor, if applicable), guidelines and global standards are followed to maintain data integrity and ensure consistency across all projects.Summary of Responsibilities:Develop the Vendor Data Plan (VDP), including the Data Quality Review reconciliation section, or sponsor equivalent, for the external vendor data transfer(s), obtain final approvals and file document to the Trial Master File (TMF) as applicable.Responsible for communication and managing relationship with external vendor and sponsor counterparts for study expectations including milestones, deliverable timelines, communication expectations, etc.May participate in review of external vendor Statement of Work (SOW) for study scope, and ensure all protocol specified parameters are present as applicable.Ensure electronic external vendor data transfers contain all protocol specified parameters, is in correct format, and data populates to the specified fields and subjects correctly as designated in the Vendor Data Plan (VDP) or sponsor equivalent.Develop and document external data edit checks and reports in the edit check template or sponsor equivalent, obtain approvals and perform QC/UAT to verify the checks and reports are functioning properly.Review external data discrepancies generated by edit checks and reports and perform subsequent query management to resolve data issues.Maintain appropriate documentation of data issues in both study and vendor logs and follow outcome to resolution.May assist with review of draft protocols from an external data perspective and assist with review of eCRF design per protocol parameters.Work with other study team functions to gather feedback and address any issues that could impact data review or analysis.May work with clinical staff to obtain and QC local laboratory ranges and verify the normal ranges are properly attached to the subject results in the local lab data.Participate in study team and department meetings as applicable.Effectively plan and support multiple increasingly complex and high-quality external data management projects simultaneously and provide updates to line management or other relevant stakeholders as requested.Qualifications (Minimum Required):University / college degree (life sciences, health sciences, information technology or related subjects preferred).Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor's degree. Fluent in English, both written and verbal.Fortrea may consider relevant and equivalent experience in lieu of educational requirements.Language Skills Required: Speaking and Writing EnglishExperience (Minimum Required):5+ years prior experience in the pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries to include data management or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.Project Management experience strongly preferred. Basic understanding of medical terminology a plus.Strong organizational, planning, and critical-thinking skills.Well-polished, inclusive, and engaging communication skills (written and verbal) to support effective interactions with sponsors and internal colleagues.US Pay Range:
$90,000-$115,000Benefits:
All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.Application deadline is September 27, 2024.Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.Fortrea is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see our Privacy Statement.
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EDS Portfolio Lead
will support the Data Manager (LDM) with the review, maintenance, and update of external vendor data received from central vendor or local laboratories. Working to ensure company SOPs (or sponsor, if applicable), guidelines and global standards are followed to maintain data integrity and ensure consistency across all projects.Summary of Responsibilities:Develop the Vendor Data Plan (VDP), including the Data Quality Review reconciliation section, or sponsor equivalent, for the external vendor data transfer(s), obtain final approvals and file document to the Trial Master File (TMF) as applicable.Responsible for communication and managing relationship with external vendor and sponsor counterparts for study expectations including milestones, deliverable timelines, communication expectations, etc.May participate in review of external vendor Statement of Work (SOW) for study scope, and ensure all protocol specified parameters are present as applicable.Ensure electronic external vendor data transfers contain all protocol specified parameters, is in correct format, and data populates to the specified fields and subjects correctly as designated in the Vendor Data Plan (VDP) or sponsor equivalent.Develop and document external data edit checks and reports in the edit check template or sponsor equivalent, obtain approvals and perform QC/UAT to verify the checks and reports are functioning properly.Review external data discrepancies generated by edit checks and reports and perform subsequent query management to resolve data issues.Maintain appropriate documentation of data issues in both study and vendor logs and follow outcome to resolution.May assist with review of draft protocols from an external data perspective and assist with review of eCRF design per protocol parameters.Work with other study team functions to gather feedback and address any issues that could impact data review or analysis.May work with clinical staff to obtain and QC local laboratory ranges and verify the normal ranges are properly attached to the subject results in the local lab data.Participate in study team and department meetings as applicable.Effectively plan and support multiple increasingly complex and high-quality external data management projects simultaneously and provide updates to line management or other relevant stakeholders as requested.Qualifications (Minimum Required):University / college degree (life sciences, health sciences, information technology or related subjects preferred).Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor's degree. Fluent in English, both written and verbal.Fortrea may consider relevant and equivalent experience in lieu of educational requirements.Language Skills Required: Speaking and Writing EnglishExperience (Minimum Required):5+ years prior experience in the pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries to include data management or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.Project Management experience strongly preferred. Basic understanding of medical terminology a plus.Strong organizational, planning, and critical-thinking skills.Well-polished, inclusive, and engaging communication skills (written and verbal) to support effective interactions with sponsors and internal colleagues.US Pay Range:
$90,000-$115,000Benefits:
All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.Application deadline is September 27, 2024.Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.Fortrea is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see our Privacy Statement.
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