Associate Director data management

AstraZeneca India; Singapore; Hybrid; SGD 120,000 - 180,000; Full time

Job summary

A leading biopharmaceutical company is seeking an Associate Director in Data Management to lead teams and oversee data quality for clinical trials. The role requires significant industry experience and aims to make impactful contributions to healthcare. Join us and play a crucial part in innovative solutions for complex diseases.

Qualifications

• Significant CDM experience from CRO and Pharma industry.
• High attention to detail and strong analytical mindset.
• Excellent communication and interpersonal abilities.

Responsibilities

• Oversee the delivery of high-quality data for projects.
• Manage vendor contracts and budget for CDM activities.
• Provide training and coaching to junior colleagues.

Skills

Clinical Data Management

Project Management

Data Quality Assurance

Interpersonal Skills

Analytical Skills

Negotiation Skills

Education

University or college degree in life sciences

Pharmacy or nursing degree

Tools

SQL

VBA

R software

Job description

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

Position Type: People manager

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

1. Provide training and coaching to junior colleagues within CDM.
2. Perform line management responsibilities such as performance appraisals and mentoring.
3. Represent Clinical Data Management at cross-functional forums and meetings, providing timely feedback to partners.
4. Understand health authority requirements and provide input into CDM-related activities associated with regulatory inspections/audits.
5. Provide CDM leadership for assigned projects, taking global accountability and serving as the second line of contact at the project level.
6. Demonstrate leadership and operational expertise in strategic planning and delivery of CDM deliverables at the project level.
7. Manage vendor contracts, resourcing, budget management, and vendor performance for assigned projects and studies.
8. Communicate and negotiate effectively with all other project-level team members.
9. Apply consistent CDM processes and documentation across assigned projects to ensure data quality.
10. Oversee external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards.
11. Responsible for proactive risk management and issue resolution/escalation related to CDM improvement or technology.
12. Develop an understanding of CDASH and SDTM or other recognized industry standards.
13. Specialize in TA-specific data capture and standards, conducting lessons learned and disseminating knowledge across the organization.
14. Provide data management expertise in supporting strategic and operational aspects of Data Management at the project level.
15. Demonstrate willingness to take on and lead any project-level activity consistent with current experience in support of study delivery.
16. 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, preferably from CRO and Pharma industry in multiple therapeutic areas.
• 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.
• Knowledge of database structures and of capturing and storing clinical information, CRF design, database development, data handling, and reporting.
• Excellent interpersonal skills and 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 large Phase III trials or multiple smaller trials.
• Knowledge of SQL, 4GL, VBA, or R software.
• Experience managing teams.

At AstraZeneca, we are driven by our passion for science and our commitment to making a meaningful impact on patients' lives. We explore innovative solutions for complex diseases, integrating digital technology with scientific advancements to accelerate healthcare breakthroughs. Our collaborative environment brings together diverse expertise to create swift impacts on disease. Curious to make a difference? Apply now to join our team!