Clinical Programmer III (India)

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.

The Clinical Programmer III works on studies with minimal supervision from the senior CP and/or Director Clinical Programming.

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, including study design specifications, User’s Acceptance Test. (UAT) plans, test cases and database configuration settings in support of database set-up and edit checks programming.

Develop and/or review Data Validation Plan.

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

Review electronic Case Report Form (eCRF) Completion guidelines.

Develop and/ or validate SAS programs for metric reporting, data review listings, data import and data export set-up.

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 and adhere to the requirements of study-specific data management documents & plans.

Lead and coordinate clinical programming activities for assigned studies (including monitoring of project timelines, scope of work, budgets, resourcing needs and escalating potential problems effectively and in a timely manner).

Actively contributes/participates in study team, departmental meetings, and sponsor meetings and uses analytical approach to problem-solving.

Collaborates with peers, programmers, study teams to clarify specifications and uses expanded technical skills to meet evolving project needs.

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

Help to align clinical programming best practices, standards, global libraries and conventions within the company.

Assist in standardizing data management procedures such as documentation for departmental operating procedures.

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

Research and propose initiatives for improving efficiency.

Actively support staff learning & development.

Develops and delivers applicable DM departmental training.

Train and mentor data management and clinical programming staff.

Proactively track data management development trends and updates, in consultation with the department Director, for further alignment and improvement of current processes.

Draft and contribute as a Subject Matter Expert (SME) in the field of Clinical Programming activities to the evaluation/improvement of processes and procedures within the Quality Management System.

Requirements

To be successful you should possess:

• Life science, Computer Science, healthcare and/or related field degree.
• Minimum 2-5 years of relevant work experience.
• Minimum 2-5 years of experience in drug development and/or clinical research.
• Good knowledge of ICH-GCP(R2), GDPR/HIPPA and applicable (local) regulatory requirements.
• Good understanding of clinical data management processes.
• Experience with tools and systems for managing clinical studies.
• Experienced in technical data management practices (developing programs, validation plans, testing, and documentation).
• Solid understanding and hands-on experience with CDISC standards (i.e. CDASH, TAUGs and SDTM models).
• Strong programming skills with proficiency in Electronic Data Capture (EDC) systems, data reporting and programming languages such as PL/SQL, SAS and comparable fields.
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required.
• Strong written and verbal communication skills including good command of the English language.
• Representative, outgoing and client-focused.
• Ability to work in a fast-paced challenging environment of a growing company.
• Administrative excellence.
• Ability to simplify complex issues into understandable concepts.
• Ability to translate guidelines, rules and regulations into clear and usable recommendations.
• Eye for detail, strong technical, analytical and problem-solving skills.

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)
• Opportunity for remote/office-based* working depending on location
• 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

Disclaimers:

• Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices.

Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”