Associate Director Study Data Manager

FlexBoard; India; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

reputed company is seeking a Clinical Data Management leader to coordinate CDM deliverables for assigned studies and act as the main contact for DM vendors.

Responsibilities include leading CDM activities, collaboration with study teams, risk identification and mitigation, and mentoring junior CDM staff within a globally distributed organization.

Qualifications

• University degree in life sciences, pharmacy, nursing or equivalent.
• 8 years of experience in CDM.
• Solid knowledge of CDM and biotech/CRO industry.
• Understanding of GCDMP and regulatory requirements.
• Strong PM and CDM experience; metrics analysis expertise.
• Ability to work with external partners.
• Experience with clinical databases and EDC systems.

Responsibilities

• Coordinate CDM deliverables on assigned studies with the DM model and DM vendor.
• Serve as the first line of contact at the study level.
• Demonstrate leadership and project management in planning and delivery of CDM deliverables.
• Collaborate with study team and DM vendor; provide mentorship to DM team.
• Identify risks and work with the DM Vendor to mitigate them.
• Mentor junior Clinical Data Management colleagues.

Skills

Clinical Data Management

Project management

Vendor management

GCDMP knowledge

Stakeholder collaboration

Education

Life sciences/pharmacy/nursing degree

Tools

EDC systems

Clinical databases

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 reputed company, 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 reputed company 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. reputed company 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.


• reputed company adherence to AZ DM standards and processes for data reputed company and consistency of data capturing for assigned studies.


• reputed company input into DM reputed company activities associated with regulatory inspections/audits for assigned studies.


• reputed company 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 reputed company 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 reputed company DM experience; Exhibits expertise in metrics analysis and reporting methodologies.


• Demonstrated ability to work effectively with reputed company partners.


• Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture .