Associate Director Study Data Manager

AstraZeneca; India; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

AstraZeneca seeks an experienced CDM leader to drive data management for one or more clinical programs in India. You will lead strategic planning, ensure SDTM/CDASH compliance, and manage vendor relationships to deliver high-quality data across studies.

You will work with global teams to align processes, mentor colleagues, and support regulatory inspections with robust data management practices. Strong communication and cross-functional collaboration are essential.

Qualifications

• Significant CDM experience in CRO and pharma industries.
• Experience leading multiple trials at therapeutic program level.
• Knowledge of SDTM/CDASH and study data standards.
• Strong understanding of GCP and regulatory expectations.
• Excellent communication and global teamwork skills.
• Experience with vendor management and CRO oversight.

Responsibilities

• Provide CDM leadership for assigned projects or indications.
• Act as second line of contact at the project level.
• Oversee vendor contracts, resourcing, and budgets.
• Ensure data quality and SDTM/CDASH alignment across programs.
• Mentor CDM staff and stakeholders on processes.
• Represent CDM in cross-functional forums and audits.

Skills

CDM leadership

GCP knowledge

data management

vendor mgmt

communication

cross-functional work

Education

Life sciences degree

Pharmacy/Nursing degree

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 programlevel 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 inhouse 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 thirdparty 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 programlevel standards.
• Act as a specialist in therapeuticarea 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 crossfunctional 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 projectlevel activity consistent with current or prior experience in support of study delivery.
• Perform any CDM related adhoc 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: thirdparty vendors that support Data Management including CROs, vendors conducting Patient Safety.