Associate Director Study Data Manager

BrightHush; India; On-site; INR 3,000,000 - 4,500,000; Full time

Job summary

reputed company is seeking a senior Clinical Data Management professional to coordinate CDM deliverables across assigned studies and to serve as the primary contact for the DM vendor. You will lead DM activities, mentor junior staff, and drive adherence to data standards.

With a background in CDM, GCDMP, and strong project management, you will ensure timely, compliant data delivery and collaborate with external partners to support regulatory inspections and study milestones.

Qualifications

• University or college degree in the life sciences or pharmacy, nursing or equivalent relevant degree.
• 8 years of experience.
• Solid knowledge of Clinical Data Management and experience in the Biotech/CRO industry.
• Demonstrated understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements.
• Strong Project Management and Lead 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 (EDC).
• Demonstrate understanding and experience in query management process.

Responsibilities

• Coordinate the Clinical Data Management deliverables on assigned studies depending on the relevant DM model and DM Vendor.
• Take accountability and serves as the first line of contact at the study level.
• Demonstrate 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.
• Communicate and collaborate effectively with study level team members.
• Primary contact for DM vendor and provides mentorship and supervision to DM team leads.
• Identify risks and collaborate with the DM Vendor to mitigate the risks.
• Drive adherence to DM standards and data capture consistency across studies.
• Lead DM inspection preparation for assigned studies.

Skills

Clinical Data Management

Project Management

Lead DM experience

Data query management

External partner collaboration

EDC systems

Metrics reporting

CDM systems

Education

Life sciences degree

Tools

Clinical databases

EDC systems

CDM systems

Job description

About the position

At reputed company, we put patients first and reputed company 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 reputed company, confident to lead, willing to collaborate, and curious about what science can do, then youre 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 reputed company where teams can come together to strategize, brainstorm and connect on key reputed company. 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 were taking ambitious reputed company to tackle some of the biggest challenges of our time, from climate change to reputed company 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 reputed company. 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 Lead Data Manager/DM Team Lead 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 reputed company and consistency of data capturing for assigned studies.
• reputated company input into DM reputed company activities associated with regulatory inspections/audits for assigned studies.
• Lead DM inspection preparation for assigned studies.
• May reputed company 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/reputed company/CRO industry.
• Demonstrated reputed company understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements.
• Strong Project Management and Lead 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 .