Senior Clinical Programmer I
Job Summary
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.
TheSeniorClinical Programmer I (SrCP1) develops and coordinates clinical programming activitiesmaintainsclinical databases and other application tools supporting data capture and data processing in compliance with study-specific plans standard operating procedures industrystandardsand regulatory requirements.
The SrCP1 providesexpertisein relevant clinical programming areas and cross-functional initiatives including the development of departmental processes tools and training of staff.
The SrCP1 is a member of the Data Management staff.
Develop andmaintainall clinical programming documentations in support of implementation and ongoing data management activities.
Review and provide input/support to project teams in the development of study documentation using technical skills to meet evolving project needs
Developleadand coordinate clinical programming activities for assigned studies (including monitoring of project timelines scope of work budgets resourcing needs escalating potential problems effectively andin a timely mannerand alerting management of potential change orders)
Reviewinputand adhere to the requirements of study-specific data management documents & plans
Collaborate with peers and study teams to clarify specifications and use expanded technical skills to meet evolving project needs
Design build test and release clinical databases data visualization platforms and/or data analytic reporting tools to the production environment
Program electronic edit checks and data listingsrequiredfor data review and validation process
Lead and support application of Clinical Data Interchange Standards Consortium (CDISC) conventions during database build activities and data TAUGs and SDTM models
Develop and/orvalidateSAS programs
Understand and promote validation principles and consistently develop codein accordance withthose requirements
Define and promote programming best practices training materials globallibrariesand standard documents
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
Provide feedback on the needs of the department for tools processes resourcing and personnel
Requirements
Life science healthcare ComputerScienceand/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 ( TAUGs and SDTM models)
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
- 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.
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent that means applying your unique skill set expertise and knowledge to build partnerships with our clients in their pursuit to develop new life-improving treatments.
If youre passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science business and operations leaders we would love to get to learn more about how we can help each other grow.
Together we SHINE. find more information about our values.
Disclaimers:
*Our in-office 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. For this role you can be home-based.
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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Required Experience:
Senior IC
About Company
Allucent Clinical Research Organization™ is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, bi ... View more