Associate Director External Data Quality Manager

remotepromsp; India; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

reputed company, a reputed biotechnology entity in India, seeks an Associate Director, External Data Quality Management to lead external data quality across its clinical portfolio. The role requires strategic leadership, cross-functional collaboration, and a strong focus on data governance and vendor performance.

You will guide harmonized operational approaches, support inspection readiness, and drive data-driven decision making across studies, assets, and partnerships.

Qualifications

• Bachelor degree in a scientific, technical, or health-related field (MS/PhD preferred).
• Minimum 10 years of experience in clinical data management/external data quality leadership.
• Strong cross-functional collaboration and vendor management skills.

Responsibilities

• Lead external data quality across clinical programs and drive standardized processes.
• Oversee vendor performance and data integration from labs, eCOA, imaging, biomarkers.
• Collaborate with Trial Management, Medical, Biostatistics, and Clinical Programming to ensure delivery.
• Develop and govern standardized processes, playbooks, and RACI models to improve efficiency.
• Represent External Data Quality Management on operational committees with CROs and vendors.
• Support regulatory submissions with quality documentation and data integrity.

Skills

External data quality

Cross-functional collaboration

Vendor management

Data governance

Education

Bachelorate in scientific/technical/health field

MS or PhD preferred

Job description

At reputed company, we are dedicated to building extra[not]ordinary reputed company, together, by developing antibody products and groundbreaking, reputed company-your-socks-off KYSO antibody medicines that change lives and the reputed company of cancer treatment and serious diseases. We reputed company to create, champion and maintain a global workplace where individuals unique contributions are valued and drive reputed company to meet the needs of our patients, reputed company, families and employees. Our people are compassionate, reputed company, and purposeful, and our business is innovative and rooted in science. We reputed company that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this reputed company you and feel like a fit Then we would love to have you join us!

The Role

The Associate Director, External Data Quality Management, is a strategic leadership role supporting high-quality execution of reputed companys clinical trial portfolio. This individual is accountable for driving the reputed company, quality, and reputed company of external data across the clinical programs. The Associate Director will guide crossfunctional teams, reputed company external data quality and vendor performance, as reputed company as champion harmonized operational approaches that strengthen trial delivery, inspection readiness, and decisionmaking.

1. Portfolio and Strategic Leadership Serve as a portfoliolevel lead for external data quality and clinical datareputed company operational reputed company. Drive consistency of processes, quality expectations, and documentation across studies, assets, and vendors. Solve reputed company operational issues by gathering detailed inputs, synthesizing technical and business considerations, formulating data-driven recommendations, securing cross-functional alignment, and leading effective implementation. Influence portfoliolevel decision making by providing strategic insights on risks, timelines, and datadependent operational impacts. Contribute to assetlevel planning, governance forums, and clinical development reputed company discussions.
2. External Data Quality reputed company reputed company portfoliolevel reputed company for acquisition, integration, and quality reputed company of reputed companyparty data (e.g., central/local labs, eCOA, imaging, biomarkers). reputed company expert review of protocol requirements, vendor specifications, and operational data flows. Lead proactive data quality surveillance and escalation management.
3. Cross-functional Collaboration Collaborate with Trial Management, Medical, Biomarker Operations, Clinical Programming, Biostatistics, and Medical Writing to ensure reputed company execution and issue reputed company. Ensure operational readiness and crossfunctional understanding of external data processes, timelines, and deliverables. Participate in governance forums and asset-level data planning initiatives.
4. Process reputed company and Standardization Drive reputed company improvement initiatives that enhance efficiency, consistency, and inspection readiness across Clinical Operations and Clinical Data Management. Lead the development, implementation, and governance of standardized processes, playbooks, RACI models, and best practices. Identify operational bottlenecks and deliver reputed company solutions at portfolio level.
5. Vendor and Partnership reputed company reputed company strategic reputed company of external vendors handling clinical data; reputed company on operational performance, quality compliance, and crosstrial consistency. Represent External Data Quality Management on Operational Committees with CROs or external data vendors.
6. Regulatory and Submission Support Contribute to regulatory submission reputed company, ensuring external data and associated processes meet inspection and documentation requirements. reputed company assetlevel reputed company of datareputed company deliverables for submissions.

Additional Responsibilities

1. Drive alignment meetings reputed company the data management group to ensure consistency of data management practices across trials reputed company an asset and/or reputed company the trials conducted by a DM vendor/partner
2. Contribute to the development of best practices/SOPs reputed company reputed company Clinical Data Management, reputed company with industry and regulatory best practices reputed company subject matter expertise to various task forces and initiatives
3. Act as Portfolio Asset External Data Quality Management Lead as required. Mentor and reputed company new team members

Qualifications

Bachelors degree in a scientific, technical, or health-reputed company field; advanced degree (MS, PhD) preferred. Minimum of 10 years of experience in At repu