Job Opportunities API

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)