The Senior Clinical Programmer I (SrCP1) develops and coordinates clinical programming activities, maintains clinical databases and other application tools supporting data capture and data processing in compliance with study-specific plans, standard operating procedures, industry standards and regulatory requirements.

The SrCP1 provides expertise in relevant clinical programming areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff.

The SrCP1 is a member of the Data Management staff.

Develop and maintain all clinical programming documentations in support of implementation and ongoing data management activities.

Review and provide input/support to project teams in the development of study documentation, using technical skills to meet evolving project needs

Develop, lead and coordinate clinical programming activities for assigned studies (including monitoring of project timelines, scope of work, budgets, resourcing needs, escalating potential problems effectively and in a timely manner and alerting management of potential change orders)

Review, input and adhere to the requirements of study-specific data management documents & plans

Collaborate with peers and study teams to clarify specifications and use expanded technical skills to meet evolving project needs

Design, build, test and release clinical databases, data visualization platforms and/or data analytic reporting tools to the production environment

Program electronic edit checks and data listings required for data review and validation process





Lead and support application of Clinical Data Interchange Standards Consortium (CDISC) conventions during database build activities and data warehousing, i.e. CDASH, TAUGs and SDTM models

Develop and/or validate SAS programs

Understand and promote validation principles and consistently develop code in accordance with those requirements

Define and promote programming best practices, training materials, global libraries and standard documents

Maintain a broad overall knowledge in the field of clinical programming and clinical data management by reading literature, self-training, continuous career development, attending training classes and professional meetings etc.

Research, propose and lead process improvement initiatives

Provide feedback on the needs of the department for tools, processes, resourcing, and personnel

Life science, healthcare, Computer Science and/or related field degree

Minimum 5 years of relevant work experience

Minimum 5 years of experience in drug development and/or clinical research

Thorough knowledge of ICH-GCP(R2), GDPR/HIPPA and applicable (local) regulatory requirements

Thorough understanding of clinical data management processes

Good understanding and hands-on experiences of CDISC standards (i.e. CDASH, TAUGs and SDTM models)

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📌 Senior Clinical Programmer I (Tamil Nadu)
🏢 Allucent
📍 Tamil Nadu