Sr Clinical Data Specialist
hace 3 semanas
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 more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Job Overview:
Serve as a member of the project team with primary responsibility for clinical data review, query generation / resolution and reconciliation to support the delivery of clinical data according to client quality and integrity specifications, and project timelines and productivity targets. Potential to assist in development of project Data Management Plan, including data review guidelines / set-up of the data management systems according to project requirements. May support Lead Data Manager (LDM) with the review, maintenance, and update of external vendor data received from central vendor or local laboratories.
Summary of Responsibilities:
• Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.
• Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
• Generate, resolve and track queries to address problematic data identified during data review activities.
• Perform aggregate review of clinical data by patient, site and / or project to identify data trends (patient safety, compliance, etc.) and / or data inconsistencies that require further investigation.
• Apply quality control procedures and checks to ensure data quality standards (client and Fortrea) are achieved.
• Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRF Completion guidelines, Data Management Plans, Perform Data review utilizing all applicable documents such as protocols, CRFs (or eCRFs and eDiary) etc.
• Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
• Assist in the review of the database design and annotate the CRF (eCRF) according to the specifications.
• Create and assist in the data review guidelines, make sure to be consistent with the clinical data model, and CRF/eCRF completion / monitoring conventions.
• Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
• Ensures service and quality, meet agreed upon specifications per the DMP and scope of work in the budget.
• Collaborate 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.
• Assist with development and documentation of 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. • Effectively plan and support multiple high quality external data management projects simultaneously and provide updates to line management or other relevant stakeholders as requested.
• Performs other related duties as assigned by management.
Qualifications (Minimum Required):
• University / college degree (life sciences, health sciences, or related subjects)
Experience (Minimum Required):
• 1-3 years working on Clinical Data Management or working with Clinical Trial protocols.
• Knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
• Time management skill and ability to adhere to project productivity metrics and timelines.
• Ability to work in a team environment and collaborate with peers.
• Good organizational ability, communication, and interpersonal skills.
• Team working skills and good collaborator skills.
• Knowledge of medical terminology is preferred.
• Knowledge of science or a scientific background is preferred.
• Good oral and written communication skills.
Preferred Qualifications Include:
• Two or more years of Electronic Data Capture experience.
• Knowledge of Fortrea and the overall structure of the organization.
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.
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