Senior Clinical Data Strategy Lead

2 weeks ago

Bloemfontein, South Africa Bioforum the Data Masters Full time
Job title : Senior Clinical Data Strategy LeadJob Location : Free State, BloemfonteinDeadline : December 19, 2024Quick Recommended Links
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Minimum requirements:

  • Bachelor’s Degree, or educational equivalent, in health, clinical, biological, or mathematical sciences, or related field is required

Minimum experience:

  • 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.

Minimum requirements/competencies:

  • High-level English Language Proficiency.
  • Strong Communication and Collaboration Aptitude.
  • Possesses general data management skills.
  • Effective Project Management Competence
  • Strong leadership and team management skills to successfully lead cross-functional teams.
  • Strong Organizational and Problem-Solving Proficiency.
  • Self-Sufficient Work Ethic.
  • Proficiency in Microsoft Office Suite.
  • 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)

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