Senior Clinical Data Manager

Job not on LinkedIn

🔥 0 minutes ago

🇨🇴 Colombia – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 21%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• Lead or support data management study activities, CRO oversight, and deliverable timelines • Build and oversee EDC systems • Represent data management on Clinical Sub-teams and align CRO and client expectations for data-related deliverables • Collaborate with client stakeholders to meet milestones and deliverables with high quality • Partner with stakeholders and CROs to mitigate and resolve risks • Provide input to functional governance with strategic suppliers and resolve escalated issues • Prepare the function for submission readiness and represent it in inspections or audits • Ensure archival and inspection readiness of Data Management Trial Master File documents • Coordinate data management deliverables and milestones with Therapeutic Area Units, Clinical Operations, Statistical Programming, and Statistics • Plan and manage external Data Management budgets and timelines, analyze variances, and improve forecasting • Act as a process expert for operational and oversight models • Maintain SOPs, process maps, templates, and timelines • Prepare metrics supporting functional KPIs • Represent the function in external professional initiatives and organizations such as SCDM, CDISC, and DIA • Contribute strategic direction to continuous improvement initiatives • Ensure compliance with learning curricula, corporate, and GXP requirements • Work cross-functionally to ensure database data quality, on-time delivery, and quality of other data management deliverables

🎯 Requirements

• Bachelor's Degree in a science, health related, or information technology field required • Minimum 5 years experience in Clinical Data Management • Experience with all phases of development in one or more therapeutic areas preferred • Strong knowledge of data management best practices and technologies as applied to clinical trials • Solid understanding of clinical trial documents, including protocols, statistical analysis plans, CRFs, and study reports • Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management processes • Strong knowledge of the broad drug development process • Expertise in cross-functional interfaces with the data management function

🏖️ Benefits

• Professional growth opportunities • Work fully embedded within a pharmaceutical client program • Autonomy and ownership in the role