Associate Director data management

Job Title: Associate Director Data Management

• Work Location: Manyata Tech Park, Bangalore, India
• Work Schedule: Three days on-site, two days remote (3/2)
• Career Level: E – People manager position.

Introduction to role

Are you ready to lead and inspire a team in Clinical Data Management (CDM)? As an Associate Director, you'll oversee the delivery of high-quality data for assigned projects or indications, whether through external partners or internally run studies. You'll stay at the forefront of industry trends and serve as a subject matter expert in process development and improvement. Join us in making a difference in the world of biopharmaceuticals!

Accountabilities

As a team leader, you'll provide training and coaching to junior colleagues within CDM.

Perform line management responsibilities such as performance appraisals and mentoring.

Represent Clinical Data Management at cross-functional forums and meetings, providing timely feedback to partners.

Understand health authority requirements and provide input into CDM-related activities associated with regulatory inspections/audits.

Provide CDM leadership for assigned projects, taking global accountability and serving as the second line of contact at the project level.

Demonstrate leadership and operational expertise in strategic planning and delivery of CDM deliverables at the project level.

Manage vendor contracts, resourcing, budget management, and vendor performance for assigned projects and studies.

Communicate and negotiate effectively with all other project-level team members.

Apply consistent CDM processes and documentation across assigned projects to ensure data quality.

Oversee external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards.

Responsible for proactive risk management and issue resolution/escalation related to CDM improvement or technology.

Develop an understanding of CDASH and SDTM or other recognized industry standards.

Specialize in TA-specific data capture and standards, conducting lessons learned and disseminating knowledge across the organization.

Provide data management expertise in supporting strategic and operational aspects of Data Management at the project level.

Demonstrate willingness to take on and lead any project-level activity consistent with current experience in support of study delivery.

Perform any CDM-related ad-hoc requests from Line Manager.

Essential Skills/Experience

University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree.

Ability to successfully manage simultaneous trials and meet deadlines.

Significant Clinical Data Management 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, e.g., SDTM or CDASH.

High attention to detail and a strong analytical mind-set.

Demonstrates a 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 environment.

Good written and verbal communication skills, negotiation, collaboration, conflict management and interpersonal skills.

Cultural awareness.

Experience of CRO and vendor management.

Desirable Skills/Experience

Experience as a lead of a large Phase III trial or multiple smaller trials.

Knowledge of SQL, 4GL, VBA or R software.

Experience of managing teams.

At AstraZeneca, we are driven by our passion for science and our commitment to making a meaningful impact on patients' lives. We are dedicated to exploring innovative solutions for some of the world's most complex diseases. By integrating digital technology with scientific advancements, we aim to accelerate breakthroughs that can redefine healthcare. Our collaborative environment brings together diverse expertise from academia, biotechs, and industry to create swift impacts on disease. Here, curiosity thrives, empowering us to make bold decisions that shape the future of medicine.

Ready to make a difference? Apply now to join our team!