Clinical Programmer II

2 months ago

Chennai, India Allucent Full time

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.

We are looking for Clinical Programmer II to join our A-team (hybrid*). As a Clinical Programmer II at Allucent, you are responsible for leading and coordinating clinical programming activities and maintaining 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.

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 documentation 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 · Support application of Clinical Data Interchange Standards Consortium (CDISC) conventions during database build activities, CDASH · Review and adhere to the requirements of study-specific data management documents & plans · Develop and lead clinical programming activities for assigned studies (including monitoring of project timelines, scope of work, budgets, resourcing needs and escalating potential problems effectively and promptly) · Participates in/contributes to study team meetings and departmental meetings, uses an analytical approach to providing input and problem solving · Collaborates with peers, leads programmers and study teams to clarify specifications and uses expanded technical skills to meet evolving project needs · Understands validation principles and consistently develops code by those requirements · Comply with clinical programming best practices, global libraries and standards · Assist in standardizing data management procedures such as documentation for departmental operating procedures · Develop and maintain a broad overall knowledge of the field of clinical programming and clinical data management by reading literature, self-training, continuous professional development, attending training classes and professional meetings etc. · Propose and support initiatives for improving efficiency

Requirements

To be successful you should possess:

Life science, Computer Science, healthcare and/or related field degree · 3+ years of relevant work experience in Clinical Programming. 3+ 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 · Basic understanding of CDISC standards ( CDASH, TAUGs and SDTM models) · Experience with electronic data capture (EDC) software systems - Veeva, Rave. Experienced in technical data management practices (developing programs, validation plans, testing, and documentation) 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 · Proficiency with various computer applications such as Word, Excel, and PowerPoint · Good programming skills with proficiency in Electronic Data Capture (EDC) systems, data reporting and programming languages such as PL/SQL, SAS and comparable fields · Eye for detail, strong technical, analytical and problem-solving skills · Ability to simplify complex issues into understandable concepts.

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/hybrid* 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:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our .

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. 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.”

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