At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
Allucent (India) Pvt. Ltd. is seeking an experienced Sr. Clinical Programmer I to join the team. The Senior Clinical Programmer I 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. He/She will provides expertise in relevant clinical programming areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff.
In this role your key tasks will include:
- Design, build, test and release clinical databases to the production environment.
- Develop and maintain all clinical programming documentations in support of implementation and ongoing data management activities.
- Review and provide input to study documentation including Data Validation Plan, UAT Plan, test cases and eCRF completion guidelines.
- Program electronic edit checks and data listings required for data review and validation process.
- Develop and/or validate SAS programs for metric reporting, data import, data reconciliation and data export set-up.
- 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.
- Review, input and adhere to the requirements of study-specific data management documents & plans.
- 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).
- Participates in/contributes to/leads study team meetings and departmental meetings, uses analytical approach to providing input and problem solving.
- Collaborates with peers and study teams to clarify specifications and uses expanded technical skills to meet evolving project needs.
- Provides leadership, guidance and support to junior programmers and other department members.
- Understands and promotes validation principles and consistently develops code in accordance with those requirements.
- Defines and promotes clinical programming best practices, training materials, global libraries and standard documents.
- Lead development activities in standardizing clinical programming procedures (e.g. setting up global libraries, standard templates).
- Maintain a broad overall knowledge in the field of clinical programming and clinical data management by reading literature, self-training, continuous professional development, attending training classes and professional meetings etc.
- Research, propose and lead process improvement initiatives.
- Actively support staff learning & development within the company.
- Share relevant information at applicable team/department meetings.
- Develops and delivers applicable departmental trainings.
- Train and mentor data management and clinical programming staff.
- Participate in the interview process for new recruits.
- Represent the company at professional meetings, webinars, seminars or through blogs and publications.
- Draft and contribute as Subject Matter Expert (SME) in the field of Clinical Programming activities to the evaluation/improvement of processes and procedures within the Quality Management System.
- Assure good communication and relationships with (future) clients.
- Contribute and take part in client evaluations, visits and bid defenses.
- Support in preparation of new proposal.
