Senior Clinical Data Strategy Lead - Colombia (LATAM)

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    "departmentLabel": "Clinical Data Management",
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    "location": {
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      "postalCode": "110911",
      "addressCountry": "Colombia"
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    "datePosted": "2026-02-12",
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    "description": "<p><span style=\"font-size: 14pt\">Bioforum, bursting with opportunity!</span></p>\n<p><br></p>\n<p><span>One year contract position.</span></p>\n<p><br></p>\n<p><span style=\"font-weight: bold\"><span>Minimum requirements:</span></span></p>\n<p>Bachelor’s Degree, or educational equivalent, in health, clinical, biological, or mathematical sciences, or related field is required</p>\n<p><br></p>\n<p><span style=\"font-weight: bold\"><span>Minimum experience:</span></span></p>\n<p>A minimum of 6 years prior experience in data management within the biopharmaceutical industry or a Contract Research Organization (CRO) setting, with a requisite minimum of 4 years of service in the capacity of Data Management Lead. Alternatively, qualifications equivalent to this criterion, including a combination of education, training, and practical experience, will also be considered.</p>\n<p><br></p>\n<p><span style=\"font-weight: bold\"><span>Minimum requirements/competencies:</span></span></p>\n<ul>\n<li>High-level English Language Proficiency.</li>\n<li>Strong Communication and Collaboration Aptitude.</li>\n<li>Possesses general data management skills.</li>\n<li>Effective Project Management Competence</li>\n<li>Strong leadership and team management skills to successfully lead cross-functional teams.</li>\n<li>Strong Organizational and Problem-Solving Proficiency.</li>\n<li>Self-Sufficient Work Ethic.</li>\n<li>Proficiency in Microsoft Office Suite.</li>\n<li>In-depth knowledge of data management principles and processes, with the ability to design and implement data workflows.</li>\n<li>Proficiency in project management methodologies and tools to effectively plan, execute, and oversee data-related projects.</li>\n<li>Advanced understanding of medical terminology, pharmacology, anatomy, and physiology.</li>\n<li>Expertise in Good Clinical Practices (GCP) and a strong grasp of relevant regulatory guidelines, including experience in compliance.</li>\n</ul>\n<p><br></p>\n<p><span style=\"font-weight: bold\"><span>Responsibilities</span></span>:</p>\n<p><span style=\"font-weight: bold\"><span style=\"font-size: 12pt\">Team Leadership</span></span><span style=\"font-size: 12pt\">:</span></p>\n<ul>\n<li><span style=\"font-size: 12pt\">Supervise the data operations team on small to mid-size projects throughout the entire database development process, focusing on maintaining high-quality data definitions and executing tasks from study initiation to database finalization.</span></li>\n<li><span style=\"font-size: 12pt\">Provide oversight ensuring that project milestones are met within designated timelines and in accordance with established Standard Operating Procedures (SOPs), Work Instructions (WIs), and International Conference on Harmonization - Good Clinical Practice (ICH GCP) guidelines.</span></li>\n<li><span style=\"font-size: 12pt\">Directly manage the data operations team, assigning and coordinating project related tasks and requests, setting clear objectives, and ensuring that team members adhere to specified deadlines.</span></li>\n<li><span style=\"font-size: 12pt\">Foster and sustain open and robust communication channels with the data operations team, as well as with all relevant stakeholders to promote collaboration.</span></li>\n<li><span style=\"font-size: 12pt\">Act as the primary point of contact for addressing unresolved study-related issues, collaborating closely with both internal and external team members to identify and implement appropriate resolutions.</span></li>\n<li><span style=\"font-size: 12pt\">Collaborate with Bioforum management to ensure Project Health (Resourcing, Budget, SOW and compliance) aligns with organizational expectations.</span></li>\n<li><span style=\"font-size: 12pt\">Provide constructive feedback to study team members to encourage growth and performance.</span></li>\n<li><span style=\"font-size: 12pt\">Assume the role as Program Manager/Oversight for single service DM projects to ensure consistency across studies.</span></li>\n<li><span style=\"font-size: 12pt\">May serve as secondary point of contact in support of primary Principal Clinical Data Strategy Leads.</span></li>\n</ul>\n<p><span style=\"font-size: 12pt\"> </span></p>\n<p><span style=\"font-weight: bold\"><span style=\"font-size: 12pt\">Service Management</span></span><span style=\"font-size: 12pt\">:</span></p>\n<ul>\n<li><span style=\"font-size: 12pt\">Collaborate with stakeholders to define project scope, objectives, and deliverables.</span></li>\n<li><span style=\"font-size: 12pt\">Provide input on the Data Management component for project plans, timelines, budgets, and resource requirements.</span></li>\n<li><span style=\"font-size: 12pt\">Independently manage functional project risks and issues, implementing mitigation strategies as needed.</span></li>\n<li><span style=\"font-size: 12pt\">Support DM service delivery with in-depth DM process and technical expertise in executing projects.</span></li>\n<li><span style=\"font-size: 12pt\">Serve as escalation point for unresolved data issues – work with external and internal team members on appropriate resolutions.</span></li>\n<li><span style=\"font-size: 12pt\">Utilize tools and software to analyse data and identify trends, anomalies, or patterns.</span></li>\n<li><span style=\"font-size: 12pt\">Participate in and support RFP process (review RFP documents, pricing, attend bid defense).</span></li>\n</ul>\n<p><span style=\"font-size: 12pt\"> </span></p>\n<p><span style=\"font-weight: bold\"><span style=\"font-size: 12pt\">Documentation and Reporting:</span></span></p>\n<ul>\n<li><span style=\"font-size: 12pt\">Maintain accurate and up-to-date project documentation, including project plans, meeting minutes, and correspondence.</span></li>\n<li><span style=\"font-size: 12pt\">Generate project-related reports and metrics to monitor project performance and ensure transparency.</span></li>\n<li><span style=\"font-size: 12pt\">Ensure timely and appropriate filing of all Data Management project documentation.</span></li>\n</ul>\n<p><span style=\"font-size: 12pt\"> </span></p>\n<p><span style=\"font-weight: bold\"><span style=\"font-size: 12pt\">Quality Control &amp; Assurance</span></span><span style=\"font-size: 12pt\">:</span></p>\n<ul>\n<li><span style=\"font-size: 12pt\">Ensure adherence to data management and organizational protocols, standards, and regulatory requirements.</span></li>\n<li><span style=\"font-size: 12pt\">Maintain data integrity and compliance with relevant regulations (e.g., FDA, GCP, CDISC).</span></li>\n<li><span style=\"font-size: 12pt\">Ensure the implementation of quality controls measures within data management operations to verify data accuracy and consistency.</span></li>\n<li><span style=\"font-size: 12pt\">Act as the Data Management (DM) Liaison during both internal and external audit processes.</span></li>\n<li><span style=\"font-size: 12pt\">Engage in collaborative efforts with Quality Assurance (QA) and Bioforum management to address Corrective and Preventive Actions (CAPAs) as required.</span></li>\n</ul>\n<p><span style=\"font-size: 12pt\"> </span></p>\n<p><span style=\"font-weight: bold\"><span style=\"font-size: 12pt\">Customer Management</span></span><span style=\"font-size: 12pt\">:</span></p>\n<ul>\n<li><span style=\"font-size: 12pt\">Serve as primary point of contact for customers and takes overall responsibility on all data management activities and deliverables.</span></li>\n<li><span style=\"font-size: 12pt\">Foster and sustain open communication and strong customer relationships to ensure contractual obligations and customer expectations are met.</span></li>\n<li><span style=\"font-size: 12pt\">Provide customers with project management expertise on data aspects to assist with key decisions and to enable continuous project/process improvements.</span></li>\n<li><span style=\"font-size: 12pt\">Provide justification for and perform direct negotiations with customers e.g., timelines, study finances, process, and resourcing.  </span></li>\n<li><span style=\"font-size: 12pt\">Attend face-to-face meetings with clients to establish and maintain strong, positive relationships.</span></li>\n</ul>\n<p><span style=\"font-size: 12pt\"> </span></p>\n<p><span style=\"font-weight: bold\"><span style=\"font-size: 12pt\">Efficiencies and Innovation:</span></span></p>\n<ul>\n<li><span style=\"font-size: 12pt\">Take an active role in the development and execution of emerging technologies and/or initiatives.</span></li>\n</ul>\n<p><span style=\"font-size: 12pt\"> </span></p>\n<p><span style=\"font-size: 12pt; font-weight: bold\">Mentorship &amp; Training:</span></p>\n<ul>\n<li><span style=\"font-size: 12pt\">Provide training to junior Data Strategy Leads (DSLs) on Data Management (DM) aspects.</span></li>\n<li><span style=\"font-size: 12pt\">Serve as Subject Matter Expert (SME)</span></li>\n</ul>",
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