• Provides clinical programming technical support and expertise across the DM/Clinical Programming function and other departments as needed.
• Provides application administration and technical support as the subject matter expert on all core business packages, including but not limited to: Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS, and supplemental packages such as migration mentoring/review, reporting tools, custom functions, etc. Utilizes primary development tools and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures.
• Generates and maintains all required documentation including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRF)s, database creation, coding setup, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports
• Monitors applications proactively for workflow alerts, system errors, performance issues and troubleshoot programming deliverable defects.
• Performs system integrations activities, application updates, and user acceptance testing.
• Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
• Participates in and provides input at project review and departmental review meetings. Participates in bid defenses. May act as primary customer interface representing the department at client meetings; may present status updates at Senior Management meetings.
• Ensures high quality deliverables by providing senior review of ’program level’/multi-study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits.
• Reviews and provides input on study budgets, manages project level metrics, progress, and status, for large programs of studies from key sponsors. Monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Assists with the creation of change orders.
• Provides leadership, mentorship, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams and/or requestors to clarify and finalize specifications and uses expanded technical skills to meet evolving project needs.
• Attends Quick Start Camps (QSCs) in the lead Clinical Programmer role for assigned studies.
• Provides leadership/oversight of five (5) to twenty (20) concurrent studies depending upon scope, similarity, program, and resourcing requirements. This may include the oversight of other lead programmers and their associated studies.
• Manages project resources, proactively alerting management of delivery and resourcing needs.
• Assists with management of application vendors and serves as an initial escalation contact. Monitors vendor service level agreements (SLAs) and reports metrics to upper management.
• Supervises the implementations of upgrades and new modules of remotely hosted vendors, acquiring all documentation and storing in the relevant areas.
• Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.
• Contributes towards the update of standard operating procedures and work instructions in line with department and company process and policy
• Proposes and leads the development of process improvements, clinical programming tools for standardization and efficiency, and the development of new concepts, technologies and products to meet emerging customer needs.
• As required, oversees program level clinical programming operations by providing supervision for a team of clinical programmers. Responsibilities may include professional development performance appraisals, and employee advising for junior staff. Assigns project work and reviews workload for all direct reports. Manages staff development by establishing goals that will increase knowledge and skill levels and by delegating tasks commensurate with skill level. Resolves conflicts/priorities at the program level prior to making any recommendations to management. Advises on administrative policies and procedures, technical problems, priorities, and methods.
• Performs other work-related duties as assigned.
• Minimal travel may be required.
• Bachelor’s degree, Master’s degree preferred, In lieu of Bachelor’s degree, equivalent related education and experience.
• The ability to deal effectively with sponsors and internal customers at all levels.
• Working experience in clinical Metadata Repository (MDR)
• Experience: 8+ years with Medidata Rave. Required experience as Rave SME.
• Skills: Rave Core Configuration changes, Migration, EDC Build, Complex Custom Functions, Data Studio (technical exposure).
• Leadership: Training & mentoring team members, some leadership abilities expected
• Excellent communication and interpersonal skills, both written and spoken, with an ability to inform.
• Demonstrated experience in managing multiple priorities in a highly dynamic environment
• Experience working in a matrix-structured environment is preferred
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail
• Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred.
• Experience in mentoring others in clinical trial process.
• Ability to read, write, speak and understand English.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
