Senior External Data Specialist

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. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Job Overview:

May support Lead 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.
• Collaborate with external vendor and sponsor counterparts for study expectations including milestones, deliverable timelines, communication expectations, etc.
• 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 high quality external data management projects simultaneously and provide updates to line management or other relevant stakeholders as requested
• Complete Fortrea and sponsor (if applicable) training in a timely manner and perform job functions in accordance with set guidelines.
• All other duties as needed or assigned.

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 Bachelors degree will be accepted in lieu of a bachelor’s degree.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Fluent in English, both written and verbal.

Experience (Minimum Required):

• 4+ years prior experience in the pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries 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
• Strong negotiation skills to facilitate, guide, influence, and produce a unified approach within a global, cross-functional environment.
• Ability to handle multiple tasks in a timely and professional manner under demanding conditions.
• Ability to use standard Microsoft suite of software products.
• Strong technical aptitude.
• Ability to maintain confidentiality of data and information during interaction with staff at all levels.
• Understanding of ICH-GCP principles

Physical Demands/Work Environment:

• Perform in a general or remote office setting.
• Sit for sustained periods of time in front of monitor.
• Perform with multiple interruptions.
• Requires frequent priority adjustment.
• Requires the ability to manage multiple priorities.
• May be required to work minimal nights and weekends to support project deadlines, milestones, and deliverables, as applicable.
• Travel Requirements:
• Global % of time: less than 10% Some travel may be required, but not extensively. Travel destinations primarily include other Fortrea facilities and/or client locations.

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.

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If, as a result of a disability, you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.