Date Posted: 13 June 2024
Location: Bangalore
Industry: Pharma / Healthcare / Clinical Research
Application Deadline: 20th June 2024
About AstraZeneca:
AstraZeneca is a leading global biopharmaceutical company, with a meaningful impact on the UK economy through significant investments in jobs and wealth creation. A report commissioned in 2009 highlights AstraZeneca’s contributions beyond its medicines, including the economic benefits provided to the nation.
Job Description:
Position: Associate Director Project Data Manager
Key Accountabilities:
- Provide Clinical Data Management (CDM) leadership for assigned projects, indications, and/or studies based on project size and scale.
- Take global accountability and serve as the second line of contact at the project level.
- Engage in strategic planning and delivery of CDM deliverables at the project level.
- Manage and oversee vendor contracts, resources, and budgets.
- Monitor and ensure vendor performance for assigned projects and studies.
- Proactively manage risks and resolve issues related to CDM improvements or technology.
Responsibilities:
- Strategic planning and delivery of CDM deliverables.
- Management and oversight of vendor contracts and performance.
- Resourcing and budget management.
- Risk management and issue resolution/escalation.
- Leadership in CDM at project and study levels.
Candidate Profile:
Qualifications:
- University or college degree in life sciences, pharmacy, nursing, or an equivalent relevant degree.
- Significant experience in Clinical Data Management, preferably from both CRO and Pharma industry across multiple therapeutic areas.
- Deep understanding of clinical trials methodology, GCP, GDMP, and medical terminology.
- Comprehensive knowledge of clinical standards (e.g., SDTM, CDASH).
- Strong analytical mindset and high attention to detail.
- Proficient in database structures, CRF design, database development, data handling, and reporting.
- Excellent interpersonal, written, and verbal communication skills.
- Proven ability to operate effectively in a global environment with cultural awareness.
- Experience managing CRO and vendor relationships.
- Demonstrated leadership in large Phase III trials or multiple smaller trials.
- Knowledge of SQL, 4GL, VBA, or R software.
- Experience managing teams and handling regulatory inspections.
- Project management training is desirable.
Additional Information:
- Job Location: Bangalore
- Qualification: University or college degree in life sciences or related subject, pharmacy
- Industry Type: Pharma / Healthcare / Clinical research
- Application End Date: 20th June 2024
Interested candidates are encouraged to apply before the end date. This role offers a dynamic and challenging opportunity to contribute to cutting-edge clinical research and make a significant impact on global health outcomes.