Job Description

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment.

The Manager, Clinical Programming (Mgr. CP) manages and oversees all planning and operational aspects of clinical programming activities from study start-up to execution, study closure and final archiving.

This position provides leadership and expertise in relevant technical areas and cross-functional initiatives and including the development of departmental processes, tools, and training of staff. The Mgr. CP is a member of the Data Management staff.

Key Competencies

• 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 required
• Strong programming skills with proficiency in EDC systems, data reporting and programing languages such as basic SAS
• Ability to simplify complex issues into understandable concepts
• Attention to detail, strong analytical and problem-solving skills
• Ability to translate guidelines, rules and regulations in clear and usable recommendations
• Strong leadership skills
• Project management skills and experience
• Effective at problem solving, strategic thinking and conflict resolution
• Good presentation and networking capabilities
• Well organized
• Good negotiating skills and financial awareness
• Life science, Computer science, healthcare and/or business degree and/or minimum of 7+ years of relevant clinical programming experience within Contract Research Organization (CRO), Pharmaceutical or biotech industries
• Minimum of 7 years of experience in drug development and/or clinical research
• Thorough knowledge of ICH-GCP(R2), GDPR/HIPPA, CDISC, GCDMP and applicable (local) regulatory requirements
• In-depth knowledge of clinical trial processes, Electronic Data Capture (EDC) systems, data structures and relevant programming languages for data manipulation and reporting.
• Proficiency in the data management practices, including tools and processes
• Solid understanding and hands-on experiences of CDISC standards (i.e. CDASH and SDTM models and mapping)
• Demonstrated experience in managing a team

Requirements

• Management

• Support, analyze and implement new development plans and actively participate in the Global Clinical Programming team meetings to identify and support the implementation of new department related goals and strategies
• Contribute to the development of the department strategy planning
• Develop and review operating procedures / business processes
• Line Management of direct reporting staff
• Assess and manage the needs of the department for tools, processes, resourcing, and personnel
• Ensure compliance with quality management documentation
• Ensure activities meet and integrate with organizational requirements for quality management, health and safety, legal stipulations, environmental policies and general duty of care
• Working closely with the (Associate) Directors to ensure global consistency, focus and development are achieved across the company
• Support management of contractual and financial aspects of projects
• Formulate short-term and long-term strategies to improve clinical programming efficiencies
• Clinical Programming

• Manage/coordinate/perform clinical programming activities, including EDC design and implementation, report generation for data cleaning and support for other departments
• Implement and maintain standardization by providing innovative and forward-thinking reporting solutions, global library templates, macros and other solutions for use across all projects.
• Ensures latest standards are being utilized, current technologies are deployed.
• Recognize and solve potential problems and evaluate effectiveness.
• Responsible for creating efficiencies in the clinical data flow ensuring the highest level of consistency and quality across projects.
• Applies expertise to identify gaps and proposes solutions to improve efficiency of programming tasks to improve overall quality of programming deliverables.
• Collaborates with cross-functional project teams during study start up and execution to ensure overall success of project.
• Plan project resources including management of tasks, timelines, risk and quality
• Serve as project advisor/consultant to cross-functional project teams regarding technical and operational aspects of project.
• Perform and/or support Clinical Programming operational activities (as necessary)
• Learning & Development

• Actively manages and mentors Clinical Programming staff
• Conduct performance evaluation and career development review
• Participates in the interview process for new recruits
• Represent the company at professional meetings and/or seminars
• Provide and coordinate Data Management training/coaching and evaluation for relevant staff
• Quality Management

• Review, improve and evaluate clinical programming processes and procedures within the Quality Management System
• Account Management, Sales & Acquisition

• Monitor and assure client satisfaction on existing projects
• Support business development in preparation of new proposals
• Contribute and take part in client evaluations, visits and bid defenses
• Others

• Contribute to other areas of business as required
• 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 required
• Strong programming skills with proficiency in EDC systems, data reporting and programing languages such as basic SAS
• Ability to simplify complex issues into understandable concepts
• Attention to detail, strong analytical and problem-solving skills
• Ability to translate guidelines, rules and regulations in clear and usable recommendations
• Strong leadership skills
• Project management skills and experience
• Effective at problem solving, strategic thinking and conflict resolution
• Good presentation and networking capabilities
• Well organized
• Good negotiating skills and financial awareness

Benefits

Education Requirements and Qualifications

• Life science, Computer science, healthcare and/or business degree and/or minimum of 7+ years of relevant clinical programming experience within Contract Research Organization (CRO), Pharmaceutical or biotech industries
• Minimum of 7 years of experience in drug development and/or clinical research
• Thorough knowledge of ICH-GCP(R2), GDPR/HIPPA, CDISC, GCDMP and applicable (local) regulatory requirements
• In-depth knowledge of clinical trial processes, Electronic Data Capture (EDC) systems, data structures and relevant programming languages for data manipulation and reporting.
• Proficiency in the data management practices, including tools and processes
• Solid understanding and hands-on experiences of CDISC standards (i.e. CDASH and SDTM models and mapping)

Demonstrated experience in managing a team