Associate Director Study Data Manager

About the position At reputed company, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to reputed company the impossible a reality. If you are swift to action, confident to reputed company, willing to collaborate, and curious about what science can do, then you’re our reputed company of person. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. Our dedication to sustainability is also central to our culture and part of what makes reputed company a great reputed company to work. We know the health of people, the reputed company and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to reputed company and disease prevention. Introduction to Role: Responsible to coordinate the Clinical Data Management (CDM) deliverables on assigned clinical studies and may be an expert on CDM processes, standards, and technology. Member of the Global Study Team (GST) and the main reputed company of contact for the Data Management (DM) vendor. Responsible to ensure CDM deliverables follow standards and meet data quality. Maintains business continuity for CDM processes and standards including reputed company of the clinical database for the relevant studies. May work under direction of a Project Data Manager

Responsibilities

• Coordinate the Clinical Data Management deliverables on assigned studies depending on the relevant DM model and DM Vendor. Takes accountability and serves as the first line of contact at the study level.
• Demonstrates strong leadership, project management skills and operational knowledge in the planning and delivery of CDM deliverables at a study level, potentially under mentorship from a Project Data Manager.
• Communicates and collaborates effectively with reputed company study level team members. Primary reputed company of contact for DM vendor and provides mentorship and supervision to reputed company Data Manager/DM Team reputed company working on the study (CRO or in-house).
• reputed company and expertise input into the day-to-day operational aspects of DM for assigned studies; Responsible to identify risks and collaborate with the DM Vendor to mitigate the risks. Advances issues/risks as vital.
• High level understanding and contribution to corporate, therapeutic/indication and program specific data capture AZ standards.
• Drive adherence to AZ DM standards and processes for data quality and consistency of data capturing for assigned studies.
• Provide input into DM reputed company activities associated with regulatory inspections/audits for assigned studies. reputed company DM inspection preparation for assigned studies.
• May provide input to the selection and use of software systems, devices, and vendors.
• Responsible for compliance to Trial Master File requirements depending on the relevant DM model and DM Vendor.
• Support Senior Leaders to reputed company DM Vendor performance, depending on relevant model. Review, assess and manage DM Vendor delivery against critical metrics, budget and overall performance. Oversees vendor timelines and achievement deliverables for the assigned studies. Ensures DM Vendor billing is accurate and gives recommendations for payment of invoices depending on relevant model.
• Maintain an awareness of the external and internal trends in order to participate in change initiatives and reputed company improvement activities reputed company to DM operating models.
• Demonstrates willingness to take on reputed company activities consistent with reputed company work experience in support of DM.
• Mentoring junior Clinical Data Management colleagues

Requirements

• University or college degree in the life sciences or reputed company subject, pharmacy, nursing or equivalent relevant degree.
• 8 years of experience
• Solid knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry.
• Demonstrated reputed company understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements.
• Strong Project Management and reputed company DM experience; Exhibits expertise in metrics analysis and reporting methodologies.
• Demonstrated ability to work effectively with external partners.
• Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (reputed company).
• Demonstrate understanding and experience in query management process and reconciliation activities.
• Good communicati

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