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Mgr, Clinical Programming

2+ years
Not Disclosed
10 March 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Mgr, Clinical Programming

Updated: February 25, 2025
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25001416

Job Title: Manager, Clinical Programming

Company: Syneos Health

About Syneos Health:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our Clinical Development model prioritizes customers and patients, simplifying operations and enhancing efficiency. With 29,000 employees across 110 countries, we collaborate to drive innovation and improve lives.

Why Syneos Health?

  • Career development, training, and progression opportunities.
  • Supportive and engaged line management.
  • A culture that values diversity, inclusion, and belonging.
  • Recognition through our Total Rewards Program.

Job Responsibilities:

  • Manage clinical programming operations, including direct line management of managers and non-management staff.
  • Oversee professional development, performance appraisals, and employee counseling.
  • Assign project work and review workload for all direct reports.
  • Resolve conflicts and prioritize tasks at the site level before escalating to management.
  • Develop and deliver training materials for Clinical Programming operations.
  • Generate and maintain all required documentation, including:
    • Annotated Case Report Forms (CRFs)
    • Database creation and coding setup
    • Edit check procedures
    • Import/export setup and processing
    • Listings and custom reports
  • Estimate hours needed for change orders and gain approval from senior/project management.
  • Represent Data Operations at project and departmental review meetings.
  • Ensure high-quality deliverables by reviewing core deliveries, performing in-progress audits, and attending sponsor audits.
  • Prepare activity, resource, and progress reports for upper management.
  • Participate in the development of project-specific software applications, ensuring compliance with documentation and validation requirements.
  • Utilize development tools, including Oracle RDC, Oracle Inform, Medidata Rave, SAS, and others.
  • Review and manage study budgets, study-level metrics, progress, and status, including large-scale programs.
  • Maintain site-level utilization/realization and ensure backlog and forecasting reviews are accurate.

Qualifications:

  • Bachelor’s degree required, Master’s degree preferred. Equivalent related education and experience will be considered.
  • Strong ability to interact effectively with sponsors and internal teams at all levels.
  • Excellent written and verbal communication skills.
  • Proven experience in managing multiple priorities in a dynamic environment.
  • Experience working in a matrix-structured environment preferred.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail.
  • Experience with programming languages (PL/SQL, SAS, C#, or VB) preferred.
  • Ability to travel up to 25% if required.

About Syneos Health’s Impact:

  • Worked on 94% of all Novel FDA Approved Drugs in the past five years.
  • Supported 95% of EMA Authorized Products.
  • Conducted 200+ studies across 73,000 sites with 675,000+ trial patients.

Additional Information:

  • Responsibilities may change at the company’s discretion.
  • Equivalent experience, skills, and education will be considered.
  • Syneos Health complies with EEO and ADA requirements, ensuring fair employment practices.