Hybrid Senior Clinical Programmer

at Allucent

• Job title: Senior Clinical Programmer
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform, SQL
• Location requirements: Hybrid, Bengaluru, India

About the role

• Senior Clinical Programmer I developing clinical databases for biopharmaceutical companies. Collaborating on clinical programming activities and ensuring compliance with regulatory requirements.

Responsibilities

• 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.

Requirements

• **To be successful you should possess:**
• 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).
• Expert with electronic data capture (EDC) software systems and other tools for managing clinical studies.
• Expert in technical data management practices (developing programs, validation plans, testing, and documentation).
• Strong written and verbal communication skills including good command of English language.
• Representative, outgoing and client focused.
• Ability to work in a fast-paced challenging environment of a growing company.
• Administrative excellence.
• Proficiency with various computer applications such as Word, Excel, and PowerPoint.
• Expert programming skills with proficiency in Electronic Data Capture (EDC) systems, data reporting and programing
• languages such as PL/SQL, SAS and comparable field.
• Eye for detail, strong technical, analytical and problem-solving skills.
• Ability to simplify complex issues into understandable concepts.
• Ability to translate guidelines, rules and regulations in clear and usable recommendations.

Benefits

• **Benefits of working at Allucent include:**
• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Leadership and mentoring opportunities
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees