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Associate Director (Group Head), Clinical Data Acquisition And Management (Clinical Data Science)

0-2 years
Not Disclosed
20 Feb. 7, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Data Acquisition and Management Lead


Summary

The role involves leading a community of approximately 20 Clinical Data Acquisition Specialists, Clinical Data Scientists, and Coding Specialists assigned to a Therapeutic Area (TA). Responsibilities include ensuring adequate staffing, resource allocation, managing attrition, hiring, talent retention, employee engagement, and career development. The role requires facilitating resource-sharing to meet company objectives and contributing towards TA-community goals and KPIs (quality, cost, cycle-time, and productivity). Additionally, the position involves supporting functional mentors to establish learning networks across Clinical Data Acquisition and Management (CDAM) and implementing initiatives to maintain Novartis Clinical Data Acquisition and Management as an industry leader.


About the Role

Major Responsibilities

  • Select, recruit, develop, manage, motivate, coach, and evaluate the performance of direct reports.

  • Foster a customer- and partner-oriented culture within Clinical Data Acquisition and Management.

  • Assign resources and manage workload within the community while ensuring resource-sharing to meet company objectives.

  • Partner with functional mentors and experts within CDAM to empower associates and drive issue resolution at the trial/program level.

  • Maintain compliance with Health Authority requirements and participate in inspections when necessary.

  • Build and maintain a high-performing team with strong technical abilities, excellence in execution, and alignment with Novartis values.

  • Lead and support non-clinical special projects and initiatives, providing subject matter expertise when needed.

  • Identify training needs and ensure training programs are conducted and documented for technical and professional skill development.

  • Ensure high-quality communication and information flow regarding trial status and proactively mitigate risks.

  • Ensure associates track time for capacity forecasting and productivity evaluation.

  • Act as a deputy for the Senior Group Head of CDAM as needed.

  • Engage with industry working groups and organizations to maintain external focus and influence industry best practices.


Key Performance Indicators

  • Achieve annual goals set by the Global Head, CDAM.

  • Ensure project deliverables meet quality, time, and productivity targets while adhering to business SOPs.

  • Maintain compliance and prevent critical audit findings in Clinical Data Acquisition and Management.


Job Dimensions

  • Number of Associates: 15-20

  • Financial Responsibility: Control of direct report expenditure

  • Impact on Organization:

    • Efficient resource utilization for trial/program delivery

    • Effective recruitment, retention, and development of talent

    • Achievement of portfolio KPIs (cost, quality, cycle time, and productivity)

    • Participation or leadership in non-clinical initiatives


Ideal Background

Education

  • University or college degree in Life Sciences, Computer Science, Pharmacy, Nursing, or an equivalent relevant field.

Languages

  • Fluent in English.

Experience & Professional Requirements

  • Proven leadership, collaboration, and organizational skills with the ability to manage multiple trials and meet deadlines.

  • Strong understanding of clinical trials methodology, GCP, and medical terminology.

  • Ability to anticipate challenges, manage risks, and implement proactive solutions.

  • Demonstrated agility in team leadership under pressure.

  • Strong interpersonal skills with the ability to operate effectively in a global environment.

  • Ability to influence and communicate across functions and external stakeholders.

  • Minimum of 10 years of experience in Drug Development, with at least 6 years in Clinical Data Management.

  • At least 5 years of line management or leadership experience.


Why Novartis?

Helping people with diseases and their families takes more than innovative science. It requires a community of smart, passionate individuals collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Learn More

Join Our Network:
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Join Novartis Talent Community

Benefits & Rewards:
Discover the various ways Novartis helps employees thrive both personally and professionally:
Read the Handbook


Position Details

  • Division: Development

  • Business Unit: Innovative Medicines

  • Location: Hyderabad, India (Office)

  • Company/Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited

  • Functional Area: Research & Development

  • Job Type: Full-time

  • Employment Type: Regular

  • Shift Work: No


Accessibility & Accommodation

Novartis is committed to providing reasonable accommodations for individuals with disabilities. If you require accommodation due to a medical condition or disability during the recruitment process or to perform essential job functions, please contact:
📧 diversityandincl.india@novartis.com
Include the job requisition number in your request.

Novartis is dedicated to fostering an outstanding, inclusive work environment and building diverse teams representative of the patients and communities we serve.