Fresh Jobs at Bioforum the Data Masters

• Bioforum has developed a revolutionary new SDTM automation tool and needs an SDTM Lead to be part of the exiting journey, leveraging this tool to deliver on our customer’s SDTM needs.
• Get in on the ground floor and become part of the growing team that will change the way SDTM conversions are done in the industry. 
• Purpose: Provide SDTM expertise and leadership in the Professional Services department of our SDTM department.

Required skills:

• B.Sc degree in Life / Computer Science, Statistics, or equivalent.
• Minimum 5 years’ SDTM experience
• In-depth knowledge of SDTM standards.
• Demonstrated ability to lead a SDTM team, communicate with stakeholders and execute SDTM delivery.
• Strong analytical and logical abilities.
• Excellent communication skills.

Duties will include:

• Leading SDTM programming teams to deliver on projects.
• Interact with the customer and provide guidance / input on the SDTM requirements and queries during the conduct of the trial.
• Oversee quality and validation requirements of SDTM delivery.
• Comply with CDISC SDTM standards.
• Create or review SDTM specifications.
• Contribute to department level initiatives to improve quality and efficiency.

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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)