Clinical Programmer Ii

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.

**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
- 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 (i.e. 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
- 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 global offices.