Senior Clinical Data Strategy Lead - South Africa

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)