Manager of Sound Design and Audio Engineering leading audio development in Paramount's Creative division. Overseeing sound design, mixing, and audio pipeline with a focus on storytelling.
About the role
- Senior Clinical Programmer I developing clinical databases for biopharmaceutical companies. Collaborating on clinical programming activities and ensuring compliance with regulatory requirements.
Responsibilities
- 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
Job title
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Degree requirement
Tech skills
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