Job Description

At Allucent(TM), 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.

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

Disclaimers:

"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."