Job Description:
The Senior Clinical Data Analyst supports all data management functions, including partnering with Study Managers and CRAs to ensure achievement of timeline and quality objectives from study launch through close-out. As an integral member of the Clinical Affairs team, this position supports management plans (DMPs), design eCRFs, and ongoing data cleaning. This position requires knowledge of clinical trials and regulations, experience conducting data analyses of multiple studies with varying designs, and the ability to perform at high levels in a fast-paced, dynamic environment. Job Responsibilities:
Additional Info:
About NeoTract : 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 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 35,000 global patients have been treated with UroLift®, and we are currently seeking exceptional talent to enable us to treat even more patients.[Click Here to Access the Original Job Post]
The Senior Clinical Data Analyst supports all data management functions, including partnering with Study Managers and CRAs to ensure achievement of timeline and quality objectives from study launch through close-out. As an integral member of the Clinical Affairs team, this position supports management plans (DMPs), design eCRFs, and ongoing data cleaning. This position requires knowledge of clinical trials and regulations, experience conducting data analyses of multiple studies with varying designs, and the ability to perform at high levels in a fast-paced, dynamic environment. Job Responsibilities:
- Assist in developing data transfer and mapping specifications, data quality review plans and the validation specifications, vendor management, and data reconciliation.
- Develop project plans for EDC build, interim, and final analysis.
- Identify process improvement needs and proactively develop efficiencies and solutions.
- Perform EDC training for internal teams and sites, and develop corresponding training manuals.
- Identify, track, and resolve routine queries.
- Oversee and conduct statistical analyses plans.
- Support ongoing study data quality, including planning, setup, performing analyses, closeout, and archiving high volume data.
- Ensure adherence to DMPs and consistency per standard operating processes.
- Collaborate with the other Clinical Affairs team members as needed.
- Perform other duties as requested.
- Contribute to the Company culture of being collaborative, respectful, transparent, ethical, efficient, high achieving, and fun!
- Bachelor’s degree in life sciences, computer science, or statistics; or equivalent practical experience.
- Master’s degree in a quantitative discipline preferred (e.g., statistics, operations research, bioinformatics, economics, computational biology, computer science, mathematics, physics, electrical engineering, industrial engineering).
- SAS Expertise required, certification preferred.
- At least 5 years of relevant 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.
- Strong knowledge of US and international clinical regulations and guidance.
- Ability to make independent decisions and take responsibility for own actions within a fast moving environment
- Ability to travel, up to 10%. Overnight travel is required. International travel may be required.
Requeriments :
Skills :
Areas :
Additional Info:
About NeoTract : 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 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 35,000 global patients have been treated with UroLift®, and we are currently seeking exceptional talent to enable us to treat even more patients.[Click Here to Access the Original Job Post]