Associate Director, Study Data Manager (Karnataka)

AstraZeneca; India; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

AstraZeneca in India seeks an experienced CDM lead to drive data management strategy and execution across global programs. The role requires coordinating with cross-functional teams and external partners to ensure timely, compliant data delivery.

Responsibilities include shaping program-level CDM standards, mentoring staff, and managing vendor relationships while upholding study quality and regulatory readiness. Strong SDTM/CDASH expertise is essential.

Qualifications

• University or college degree in life sciences or related subject (pharmacy, nursing, or equivalent relevant degree).
• Ability to successfully manage simultaneous trials and meet deadlines.
• Significant CDM experience, preferable both from CRO and pharma industry in more than one therapeutic area.
• Excellent understanding of clinical trials methodology, GCP, GDMP and medical terminology.
• Comprehensive knowledge of clinical standards such as SDTM or CDASH.
• High attention to detail and strong analytical mindset.

Responsibilities

• Provide CDM leadership for assigned projects or indications, depending on size and scale of the project.
• Assume global accountability and serve as the second line of contact at the project level.
• Demonstrate leadership and operational expertise in strategic planning and delivery of CDM deliverables at program and/or project level.
• Manage and oversee vendor contracts, resourcing, and budget management, as well as oversight of vendor performance for assigned programs and projects.
• Communicate and negotiate effectively with all other program‑level team members.
• Serve as the primary point of contact for CDM at the Global Program Team GPT level.

Skills

Leadership

Negotiation

Communication skills

Analytical mindset

Attention to detail

Interpersonal skills

Cultural awareness

Vendor management

Mentoring

Education

Bachelor's degree in life sciences or related field

Tools

SQL

4GL

VBA

R

Job description

Responsibilities

• Provide CDM leadership for one or more assigned projects or indications, depending on size and scale of the project.
• Assume global accountability and serve as the second line of contact at the project level.
• Demonstrate leadership and operational expertise in strategic planning and delivery of CDM deliverables at program and/or project level.
• Manage and oversee vendor contracts, resourcing, and budget management, as well as oversight of vendor performance for assigned programs and projects.
• Communicate and negotiate effectively with all other program‑level team members.
• Serve as the primary point of contact for CDM at the Global Program Team GPT level.
• Demonstrate a business understanding of the compound profile to identify and assist in applying consistent CDM processes and documentation across assigned programs (e.g., ensuring consistency across data quality plans).
• Provide oversight and expertise of external service providers or in‑house teams to deliver quality data with compliance to study model procedures and standards; give guidance on AZ standards, processes, systems and expectations to external partners, internal partners, and third‑party vendors.
• Be responsible for proactive risk management and issue resolution escalation related to CDM improvement or technology.
• Develop an understanding of CDASH, SDTM, or other recognized industry standards and assess impact on the programming team to ensure consistency of program‑level standards.
• Act as a specialist in therapeutic‑area specific data capture and standards; conduct lessons learned and disseminate across the organization as appropriate.
• Provide CDM expertise in supporting strategic and operational aspects of Data Management at the project level.
• Mentor CDM colleagues and any stakeholder with operational processes used in studies and projects.
• Represent CDM at cross‑functional forums, meetings, and provide timely feedback to partners.
• Understand health authority requirements and provide input into CDM activities associated with regulatory inspections, audits, and liaison with Clinical Quality Assurance.
• Demonstrate willingness to take on and lead any project‑level activity consistent with current or prior experience in support of study delivery.
• Perform any CDM related ad‑hoc requests from line manager or other senior managers.

People Management

• Direct and indirect reports: none.
• Matrix manager – projects (dotted line).

Qualifications

• University or college degree in life sciences or related subject (pharmacy, nursing, or equivalent relevant degree).
• Ability to successfully manage simultaneous trials and meet deadlines.
• Significant CDM experience, preferable both from CRO and pharma industry in more than one therapeutic area.
• Excellent understanding of clinical trials methodology, GCP, GDMP and medical terminology.
• Comprehensive knowledge of clinical standards such as SDTM or CDASH.
• High attention to detail and strong analytical mindset.
• Comprehensive knowledge of database structures and of capturing and storing clinical information as they apply to CRF design, database development, data handling and reporting.
• Excellent interpersonal skills and proven ability to operate effectively in a global workplace.
• Good written and verbal communication skills, negotiation, collaboration, conflict management and interpersonal skills.
• Cultural awareness.
• Experience of CRO and vendor management.
• Desirable: experience as a lead of a large Phase III trial or multiple smaller trials.
• Knowledge of SQL, 4GL, VBA or R software.

Key Relationships

• Internal: Head of Early Data Management, Statistical and Clinical Programmers, Statistician, Clinical Colleagues, Clinical Quality Assurance and Compliance Core Team, Extended Study Team Members, Patient Safety Team, Biometric Operations.
• External: third‑party vendors that support Data Management including CROs, vendors conducting Patient Safety.