Clinical Research

• Oversee the planning, execution, and successful completion of clinical trials
• Ensure adherence to timelines, budgets, and regulatory guidelines
• Coordinate clinical trial management delivery, resolve issues, and develop team capability
• Oversee the clinical portion of the budget and ensure efficient resource allocation
• Develop monitoring plans and tools to ensure effective study oversight
• Train and mentor Clinical Research Associates (CRAs)
• Drive enrollment and lead study start-up activities
• Review trip reports and implement corrective and preventative action plans when necessary
• Foster productive relationships with Sponsors, vendors, and cross-functional teams
• Provide strategic guidance to drive successful clinical trial outcomes

Senior Clinical Trial Manager

• Provide statistical support to clinical studies
• Participate in study protocol development, study design discussions, and sample size calculations
• Review CRFs and data review guidelines
• Develop statistical analysis plans, including analysis dataset and TLG specifications
• Perform statistical analyses and interpret statistical results
• Prepare clinical study reports, including integrated summaries for submissions
• Present and explain methodology and consequences of decisions
• Understand and follow FDA regulations affecting clinical trial data reporting, including good clinical practice and electronic submission guidelines
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in developing CRFs, edit check specifications, and data validation plans
• Review or author data transfer specifications for external vendor data
• Collaborate with internal and external functions, including CROs, software vendors, and clinical development partners, to meet project timelines and goals
• Review or author SOPs and work instructions related to statistical programming practices

Senior Biostatistician

• Identify and secure new business opportunities across pharmaceutical, biotechnology, MedTech, healthcare, and life sciences industries
• Prospect and engage pharmaceutical, biotech, MedTech, CRO, clinical research, and healthcare companies
• Build and manage a strong sales pipeline from lead generation through contract closure
• Sell specialized logistics, transportation, cold chain, and supply chain solutions
• Develop relationships with key decision-makers and senior stakeholders
• Prepare proposals, presentations, RFQs, RFPs, pricing, and commercial agreements
• Lead client meetings, negotiations, and solution-selling discussions
• Collaborate with Operations, Pricing, Quality, and Customer Service teams
• Maintain accurate pipeline activity, forecasts, and client information in the CRM
• Achieve revenue, profitability, and new-client acquisition targets
• Represent the company at industry events, conferences, and networking opportunities

Business Development Manager – Clinical Trial Logistics

• 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

Clinical Research jobs in Colombia

Senior Clinical Trial Manager

Senior Biostatistician

Business Development Manager – Clinical Trial Logistics

Senior Clinical Data Manager