Clinical Data Management Specialist
NeoTract is a medical device company featuring a revolutionary technology called The UroLift® System. The UroLift® System treats BPH (benign prostatic hyperplasia) by lifting and holding the enlarged prostate tissue so it no longer blocks the urethra. It is the only BPH procedure that does not require cutting, heating, or removal of the prostate tissue. Over 60,000 patients have been treated with UroLift® and we are currently seeking exceptional talent to grow our organization.
As an integral member of the Clinical Affairs team, the Clinical Data Management Specialist supports all Clinical data management functions within timeline and quality objectives, from study launch through close-out. With oversight from management, this position develops and executes data management plans (DMPs), and builds and validates EDC, including eCRF design. This position requires a strong knowledge of EDC, experience in clinical trials and related regulations, and the ability to perform at a high level in a fast-paced, dynamic environment.
- Manage study data in various phases in high volume, from planning through closeout.
- Manage ongoing data cleaning, data locks, and supporting data analysis.
- Develop and execute project plans for EDC build, including interim and final analysis, and build eCRFs and program logic.
- Develop, execute, and maintain a robust and compliant data management plan, while adhering to data transfer, data mapping, and validation requirements.
- Conduct DMP and EDC training to internal teams and sites, anddevelop and update training manuals.
- Organize ongoing data review to ensure the highest caliber data, on time, in conjunction with monitoring and data locks.
- Maintain systems for device accountability, site payments, and media tracking.
- Follow and maintain study master files per procedures.
- Recognize process improvement needs and proactively implement efficient solutions, including SOPs and WI development.
- Partner with management to manage external vendors, including ongoing supplier qualification and accountability.
- Contribute to the development and implementation of departmental policies, standards, and process improvement initiatives.
- Work on assigned projects.
- Perform other duties as assigned.
- Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!
- Bachelor’s degree from an accredited institution with a major in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience.
- At least 3 years of clinical data management experience.
- Ability to perform well-defined procedures initially with supervision, and after direction is provided, work independently.
- Mastery of Excel (certification preferred) and MS Access.
- Experience working under US and international clinical regulations and guidance.
- Ability to make independent decisions and take responsibility for own actions within a fast-moving environment.
- Expertise in building Electronic Data Capturing systems, both out-of-box and custom.
- Knowledge of SAS input and output functions.