Senior Clinical Data Strategy Lead - South Africa

Job description

Bioforum, bursting with opportunity! Minimum Requirements: Bachelor’s degree (or equivalent education) in health, clinical, biological, or mathematical sciences, or a related field. Experience: A minimum of 8 years prior experience in data management within the biopharmaceutical industry or a Contract Research Organization (CRO) setting, with a requisite minimum of 6 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. Skills & Competencies: High-level English Language Proficiency. Possesses general data management skills. Strong leadership and team management skills to successfully lead cross-functional teams. Self-Sufficient Work Ethic. Proficiency in Microsoft Office Suite. Strong Organizational and Problem-Solving Proficiency. Effective Project Management Competence Strong Communication and Collaboration Aptitude. In-depth knowledge of data management principles and processes, with the ability to design and implement data workflows. Proficiency in project management methodologies and tools to effectively plan, execute, and oversee data-related projects. Advanced understanding of medical terminology, pharmacology, anatomy, and physiology. Expertise in Good Clinical Practices (GCP) and a strong grasp of relevant regulatory guidelines, including experience in compliance. RESPONSIBILITIES: Team Leadership: 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. 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. 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. Foster and sustain open and robust communication channels with the data operations team, as well as with all relevant stakeholders to promote collaboration. 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. Collaborate with Bioforum management to ensure Project Health (Resourcing, Budget, SOW and compliance) aligns with organizational expectations. Provide constructive feedback to study team members to encourage growth and performance. Assume the role as Program Manager/Oversight for single service DM projects to ensure consistency across studies. May serve as secondary point of contact in support of primary Principal Clinical Data Strategy Leads. Service Management: Collaborate with stakeholders to define project scope, objectives, and deliverables. Provide input on the Data Management component for project plans, timelines, budgets, and resource requirements. Independently manage functional project risks and issues, implementing mitigation strategies as needed. Support DM service delivery with in-depth DM process and technical expertise in executing projects. Serve as escalation point for unresolved data issues – work with external and internal team members on appropriate resolutions. Utilize tools and software to analyse data and identify trends, anomalies, or patterns. Participate in and support RFP process (review RFP documents, pricing, attend bid defense) Documentation and Reporting: Maintain accurate and up-to-date project documentation, including project plans, meeting minutes, and correspondence. Generate project-related reports and metrics to monitor project performance and ensure transparency. Ensure timely and appropriate filing of all Data Management project documentation. Quality Control & Assurance: Ensure adherence to data management and organizational protocols, standards, and regulatory requirements. Maintain data integrity and compliance with relevant regulations (e.g., FDA, GCP, CDISC). Ensure the implementation of quality controls measures within data management operations to verify data accuracy and consistency. Act as the Data Management (DM) Liaison during both internal and external audit processes. Engage in collaborative efforts with Quality Assurance (QA) and Bioforum management to address Corrective and Preventive Actions (CAPAs) as required. Customer Management: Serve as primary point of contact for customers and takes overall responsibility on all data management activities and deliverables. Foster and sustain open communication and strong customer relationships to ensure contractual obligations and customer expectations are met. Provide customers with project management expertise on data aspects to assist with key decisions and to enable continuous project/process improvements. Provide justification for and perform direct negotiations with customers e.g., timelines, study finances, process, and resourcing. Attend face-to-face meetings with clients to establish and maintain strong, positive relationships. Efficiencies and Innovation: Take an active role in the development and execution of emerging technologies and/or initiatives. Mentorship & Training: Provide training to junior Data Strategy Leads (DSLs) on Data Management (DM) aspects. Serve as Subject Matter Expert (SME)