Job Description
About Zenflow Zenflow, Inc. is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by enlarged prostate. The innovative Spring® technology was designed with the patient experience in mind and relies on a small spring-like coil that gently props open the urethra, restoring its normal function while preserving the natural anatomy. The Zenflow Spring System is an investigational device and is not approved for commercial sale.
PURPOSE OF JOB: We are seeking a highly skilled Clinical Data Analyst with medical writing experience to join our dynamic team at Zenflow, a medical device start-up located in South San Francisco. The ideal candidate will be responsible for managing, analyzing, and interpreting clinical data to support our innovative medical device projects. This role requires a strong background in clinical data management, statistical analysis, and medical writing to ensure accurate and comprehensive documentation of clinical trial results and regulatory submissions.
MAJOR DUTIES AND RESPONSIBILITIES: - Collect, review, and organize clinical trial data to ensure accuracy and reliability.
- Perform statistical analysis using software such as SAS, R, or Python to interpret complex clinical data.
- Prepare detailed clinical study reports, regulatory submissions, and scientific manuscripts.
- Develop and manage clinical databases, ensuring adherence to Good Clinical Practices (GCP) and Good Clinical Data Management Practices (GCDMP).
- Generate and validate clinical reports, including tables, listings, and graphs, to support data-driven decision-making.
- Work closely with cross-functional teams, including clinical research, regulatory affairs, and product development, to ensure seamless integration of clinical data into project workflows.
- Implement data quality assurance processes to identify and resolve discrepancies and ensure data integrity.
- Provide training and support for clinical data management software and tools to team members.
- Expertise in scientific publishing including clinical manuscripts, abstracts, posters, oral presentations, and journal articles.
- Experience in developing and executing publication strategies, collaborating with KOLs, researchers, and industry leaders to produce high-impact scientific content.
- Strong background in regulatory writing, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), Investigator Brochures (IBs), regulatory dossiers, and FDA Sprint Discussion Documents. Familiar with FDA, EMA, MDR, and ICH guidelines, ensuring compliance and scientific rigor in regulatory submissions.
- Highly skilled in scientific data communication and regulatory strategy, working cross-functionally with regulatory teams, medical affairs, and clinical stakeholders to support development of Zenflow’s products.
EDUCATION/EXPERIENCE REQUIREMENTS: Education and Necessary Skills: - Bachelor’s degree in a relevant field such as Health Informatics, Biostatistics, or a related discipline. Advanced degree (Master’s or PhD) preferred.
- Minimum of 3-5 years of experience in clinical data analysis and medical writing within the healthcare or medical device industry.
- Proficiency in data analysis software (SAS, R, Python), database management systems (SQL), and data visualization tools.
- Strong experience in medical writing, including preparation of clinical study reports, regulatory submissions, and scientific publications.
- Excellent analytical and problem-solving skills with the ability to interpret complex data sets.
- Strong written and verbal communication skills to effectively convey data insights to non-technical stakeholders.
- High level of attention to detail and accuracy in data management and reporting.
- Familiarity with healthcare regulations and standards, including FDA guidelines and ISO standards.
- Ability to work collaboratively in a fast-paced, start-up environment and adapt to changing priorities.
The expected hourly range for this contract position is $115.00-155.00. This range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.
Job Tags
Hourly pay, Contract work, Part time, For contractors,