Job Information
Biogen Senior Clinical Database Programmer (RAVE) in Cambridge, Massachusetts
The Senior Clinical Database Programmer (RAVE) is responsible for developing EDC database, contributing to the assessment and tracking of quality of programming tasks and activities executed by CRO and FSP vendors performing clinical trial programming work for Biogen. The position collaborates with the DM staff, management, and vendor clinical programmers to schedule and conduct the review of study documentation, build EDC database and edit checks, custom functions and perform programming quality checks and technical review related to the design and testing of EDC databases, to ensure that all clinical trial databases and electronic collection tools are consistent with the needs of the study protocol and department standards and procedures.
The Senior Clinical Database Programmer (RAVE) is also responsible for performing Clinical Data Management System Administration tasks as well as providing user management support related to Clinical Data Management Systems required for clinical studies. The position is responsible for user administration tasks for EDC, Coder, End of Study Media Portal, FTP (Managed File Transfer) system and Other DM applications.
This can be a hybrid position with 2 - 3 days per week in the Cambridge office or remote.
What You’ll Do
Participates in activities as related to building study databases and applies competent knowledge of the programming of moderate CRF design, database building, edit checks, Custom function programming, system interfaces and all system feature configurations. Provides input Trial Data Manager to define study specific database design within the CDMS system (i.e Medidata Rave), performs clinical database programming activities on multiple studies of simple to moderately complex design and expert in all areas for relevant CDMS. Ensures high quality deliverables by providing review of study-level/program –level, multi- study core deliveries for accuracy.
Perform User Administration activities for Rave EDC, Coder & EOS Media portal. Manage Site creation, subject transfer, and subject PDF creation requests. Act as User Administrator for addressing basic system access issues and escalating timely to Vendor Support team & notify the end users in case of any system outages. Perform EDC user and site administration management quality review activities for all ongoing studies on bi-annual basis and file the Quality check list reports into TMF
Serves on project teams to coordinate and lead CDMS activities for clinical database programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables and provides constructive criticism. 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. Attends sponsor audits and assists with in-progress audits, including presenting the CDMS process and procedures and presenting the validation documentation produced by the validation group.
Conducts peer review and Technical review of clinical programming deliverables from internal and vendor employees, providing analysis and trending of quality to management and feedback and training to internal and vendor employees as needed. Reviews or creates user acceptance test scripts for quality and completeness and performs UAT process to ensure high quality results, feedback, and compliance with industry and Biogen best practices.
Performs additional clinical programming tasks including but not limited to data loading, generation of metrics and report creation. Participates and contributes towards internal user group meetings to share knowledge and providing latest updates/features. Participates in Data Management department initiatives.
Who You Are
You are an experienced, passionate and skilled EDC Database Programmer. You have deep knowledge of EDC systems, CDM and validation processes.
Required Skills
4+ years Clinical Database programming experience working in the biotechnology or pharmaceutical industry; experience working with CROs highly desirable
Technical/Software Skills: Expertise with Medidata RAVE (Custom Function programming) required. PhaseForward Inform, Oracle Clinical and/or other clinical data management software desirable;
General software skills: MS Access, MS Word, MS Excel, MS Project, Visio, familiarity with medical coding dictionaries, especially MedDRA and WHODRUG.
Experience applying best practices in clinical data management programming in the clinical trial environment, including requirements definition and QC plans
Knowledge of GCP and other regulations.
Internal customer management, influence of peers, team effectiveness and enhancement, timeline management, proactive problem-solving ability, ability to develop trust, shared goals and values.
Must have excellent oral and written communication / presentation / negotiation skills.
Detail oriented, able to identify issues and consistently collaborate to solve problems in a timely manner.
Ability to handle multiple (changing) priorities under tight timelines
Education Requirements/Preferred Skills
Bachelor’s degree required, specialization in Computer Science, Information Science, Life Sciences, Clinical Data Management, or Drug Development preferred
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.