As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.
BIOTRONIK is looking to add a Clinical Data Analyst to our Clinical Data Operations (CDO) group. The Clinical Data Operations (CDO) group is responsible for providing the company’s data management services related to our clinical trials. The Clinical Data Analyst is responsible for study database design, validation, implementation, documentation, maintenance and archiving; performing validation of clinical trial data; overseeing resolution of data discrepancies; and creating ad hoc study reports.
Oversee all data management deliverables for assigned projects
Track timelines, metrics, and ensure CDO project milestones are met in coordination with the project team expectations
Develop file specifications and support development of reporting and database export code
Support electronic Case Report Form development (eCRF)
Perform clinical database development, testing, validation, maintenance and archiving
Maintain documentation of important CDO decisions and project deliverables
Provide CDO support to internal personnel and clinical sites
Answer questions and propose technical solutions specific to CDO processes
Test system enhancements or upgrades prior to implementation
Define, run, review edit checks
Resolve discrepant data unable to be addressed through routine data processing
Develop test scripts and support User Acceptance Testing as needed
Resolve user problems directly or facilitate resolution via outside vendors
Cooperate with Clinical, Regulatory, and Compliance members for data verification and final data submission to FDA, investigators, IRBs, etc.
Meet regularly with management to discuss and seek resolution to CDO issues
Participate in conference calls, site/vendor visits, and audits as needed
Ensure accuracy in manipulation and scrutiny of clinical data and that CDO activities are carried out according to SOPs and regulatory guidelines
Provide tracking and reporting for operational management of study, such as investigator compensation and study status updates
BS/BA in Healthcare Information Management , Computer Sciences, or one of the life sciences
Minimum of 3 years clinical data management experience
Demonstrated experience in EDC development
Basic degree of comfort working with relational databases such as SQL Server, MySQL, Oracle, SQLite
Demonstrated experience with Reporting Tools such as SAP Business Object, Qlik, Tableau, etc.
Knowledge of clinical research, ICH-GCP, GCDMP, FDA and related regulatory requirements.
Excellent verbal and written communication skills
Demonstrated problem solving skills
Ability to work independently, prioritize and work within a matrix team environment is essential
Knowledge of clinical research process
Demonstrated ability to evaluate challenging situations and develop alternative solutions creatively in cooperation with Sr. Manager, CDO.
Demonstrated ability to interface effectively with all levels of staff and management, both internally and externally
Demonstrated ability to build and maintain productive alliances and partnerships with internal and external clients
Quality driven, positive attitude and enthusiastic toward work
Strong communication skills (verbal and written) to express complex ideas
Excellent organizational and interpersonal skills
Ability to manage multiple priorities within a variety of complex clinical trials
Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical study settings
Understanding of basic data processing functions, including electronic data capture
Working knowledge of current GCP/ICH guidelines and FDA guidelines pertinent to clinical trial data, databases, archiving and electronic records
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to be independently mobile.
The employee is also required to interact with a computer for extended periods of time, and communicate with co-workers.
Travel Requirements: Minimal travel expectations but must have willingness and ability to travel domestically as required
Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.
Location: Lake Oswego, OR | Working hours: Full-time | Type of contract: Undefined
Apply now under: www.biotronik.com/careers
Job ID: 28538 | Contact: Amanda Willott
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.