Sr. Manager, Clinical Data Management/Biostatistics
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.
The Clinical Data Operations (CDO) group is responsible for providing the company’s data management services related to our clinical studies. The department requires a multi-disciplined department leader to execute a management strategy that fulfills the following critical functions: Clinical systems implementation, study database development, statistical data analysis, reporting, automation, investigator site contracting, and site reimbursement. The incumbent has administrative responsibility for other employees in the group and takes a leadership role in the activities outlined below.
Oversee development and maintenance of validated study databases on electronic data capture (EDC) platform. Ensure accuracy of database design, error checks, work flow, user access rights, testing procedures, software validation, and FDA required documentation.
Oversee biostatistics deliverables, including clinical programming, validation, documentation, statistical analysis, regulatory reporting, manuscript support, and sample size estimation. Develop real world evidence methodologies to supplement or enhance data collected through conventional clinical trials.
Oversee investigator site contracting, reimbursement and related data driven payment systems while ensuring compliance with Sunshine Act requirements.
Monitor effectiveness of data management systems and procedures used by the department. Implement continuous improvements with consideration for industry standards, best practices, and regulatory requirements.
Responsible for data management software vendors, including bid proposals and contract oversight. Perform periodic vendor audits and performance assessments to enforce compliance with SOPs, applicable regulations, and contractual terms.
Work with IT department to provide technical leadership and ensure the appropriate implementation of infrastructure, tools, and systems to enable the department’s strategy.
Collaborate with management team and all functional groups within the department to develop robust study protocols, effectively analyze data, promote process standardization and ensure timely provision of high quality deliverables.
Work to ensure a smoothly running department with open communication and thoughtful discussions.
BS/BA in one of the life sciences.
Minimum of 5 years direct management experience and a minimum of 5 years in clinical data management.
Thorough knowledge of current FDA regulations applicable to clinical trial data, clinical databases, electronic records, and GCP/GCDMP/ICH guidelines.
High degree of comfort working with sophisticated databases, including complex queries and joins, file structure manipulation, relational design, SQL.
Ability to work independently, prioritize, and interact within a matrix team environment is essential.
Experience building FDA compliant study databases within EDC platform.
Thorough knowledge of clinical research process from early phase through PMA submission
Demonstrated ability to evaluate challenging situations and develop alternative solutions creatively and independently
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
Demonstrated problem solving and financial negotiation skills
Strong leadership skills including meeting facilitation, cross-functional team integration, strategic thinking, negotiation, and coaching
Quality driven, positive attitude and enthusiastic toward company’s mission
Strong communication skills (verbal and written) to express complex ideas
Excellent organizational and interpersonal skills
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
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 settings
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.
Must be able to work a minimum of 40 hours / week.
Must be able to travel to other office locations.
Must be able to travel internationally and domestically, less than 20% of the time.
Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.
Location: Portland, OR | Working hours: Full-time | Type of contract: Undefined
Apply now under: www.biotronik.com/careers
Job ID: 28180 | 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.