Lead Clinical Data Programmer

6 days ago

bangalore, India Elanco Full time
At Elanco (NYSE: ELAN) – it all starts with animals As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.
We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.
We believe that diversity is the driving force behind innovation, creativity, and overall business success.
Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today Position Title: Lead Clinical Data Programmer – Data Management Supervisor Title: Director, Data Management Job Level: P2 Position Type: Full Time Job Function: Innovation, Data Management Location: Bangalore Position Description: Strategically achieve global clinical data management objectives through systems and processes used during data capture, management, reporting, storage and archival.  This will include electronic data and may include paper data collection process and systems.  This position is expected to be highly influential in partnering with product development teams and third parties to develop data management strategies that result in on-target delivery of final databases.  This position will closely collaborate with R&D functions including clinical development, internal study sites, biostatistics, regulatory affairs, and quality assurance to ensure data integrity, data quality, validation, and compliance.  Key Leadership Responsibilities * Proactively search for solutions. * Work effectively and flexibly within and across all Elanco R&D teams and external collaborators to achieve overall Elanco R&D deliverables. * Create a positive work environment that is aligned with company objectives. * Provide and accept challenge to deliver innovative technical solutions and create an innovative culture. * Create an engaging culture with a "Play to Win” mentality. * Identify and utilize methods to deliver individual objectives in a high quality, timely, cost-effective manner. * Demonstrate high levels of adaptability, flexibility, and learning agility Key Technical Responsibilities * Use SAS or other software to develop custom programming reports helping in data cleaning activities. * Ensure that outputs meet quality standards and project requirements. * Perform validation programming and work with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. * Ensure adherence to clinical data collection policies and procedures and is expected to keep Elanco at the forefront of standards for the animal health industry * Keep project team members informed of programming progress and issues requiring their attention. * Confirm validation and compliance to all regulations (including GxP) and guidelines the global data management systems and process utilized to collect, manage, report, store and archive databases containing clinical data * Be part of the regular connects with site lead and study team (Site/Study program leads). * Manage scheduling and time constraints across multiple projects at a time, set goals based on priorities from management, and adapt to timeline or priority changes by reorganizing daily workload. * Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for opinions of others. * Display willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. * Negotiate and establish accurate time estimates for completion of study programming activities with internal team members. * Assist in drafting regulatory submissions. * Ensure scientific integrity and animal welfare in all activities. * Create and maintain standard macros and applications to improve the efficiency of the department. * Proactively participate in and/or lead process/quality improvement initiatives, standardization, and other non-clinical initiatives. * Develop wider knowledge of SAS and other relevant programming languages and processes within the Data Management, Biostatistics and Medical arenas. * Contribute to the mentoring of other programmers, developing training courses, presenting training materials, providing feedback, or guiding new associates in process. * Participate in internal/external audits and regulatory inspections as required. * Engage in knowledge share activities. Minimum Qualification (education, experience and/or training, required certifications): * BSc / MSc in related fields * Minimum 10 years of relevant experience (some vaccine development experience will be a plus) * Expertise in SAS programming with associated basic and advance certifications. * Strong GxP knowledge, in particular GLP, GCP and GMP. * Good written and verbal communication skills * Experience of mentoring and coaching junior staff. * Knowledge of electronic systems and capabilities and their application in animal/human health R&D, maintenance validation and data pulls are a plus. Additional Preferences: * Clinical trial experience and/or clinical trial data experience * Knowledge of electronic data capture systems * Experience interacting with regulatory authorities and regulatory submissions * Ability to communicate logically and technically.
Deliver all communication with clarity, impact and passion tailored to the audience. * Organizational planning skills, ability to manage competing priorities and flexibility to change. * Commitment to quality. * Ability to work independently or as part of a team. * High competency in Microsoft Office. * Ability to work additional hours as required and work with staff in irregular time zones. * Ability to learn new systems and functions in an evolving technical environment. Other Information: * This position will be based in Bangalore, India as outlined with local requirements Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

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