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Clinical Data Strategy Lead
hace 1 semana
Bioforum, bursting with opportunity
Minimum Requirements:
- Bachelor's degree (or equivalent education) in health, clinical, biological, or mathematical sciences, or a related field.
Experience:
- At least 4 years of experience in data management within the biopharmaceutical industry or a CRO.
- Requisite minimum of 2 years of service in the capacity of Data Management Lead
- Equivalent combinations of education, training, and experience will also be considered.
Skills & 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.
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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.
- May serve as secondary point of contact in support of primary Senior Clinical Data Strategy Leads.
Service Management :
- Collaborate with stakeholders to define project scope, objectives, and deliverables.
- Assist in the management of project risks and issues, implementing mitigation strategies as needed.
- Support DM service delivery with solid 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.
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.
- Support Quality Assurance (QA) and Bioforum management to address project related 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.
Mentorship & Training:
- Serve as Subject Matter Expert (SME)
- Contribute to the development of training programs for the data management team to enhance their skills and knowledge.
