Clinical Data Manager III
Job Description
Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care.
Job Description
Primary Function of the Position
The candidate will manage design, develop, implement, validate, maintain, and support clinical databases related pre-market or post- market clinical studies/registries. The candidate will have an understanding of data design, development, implementation processes to develop EDC systems. The candidate will be responsible for adhering to the required departmental operating procedures regarding Data Management for clinical investigations
Essential Job Duties
- Develop project specific data management plan that includes design, creation and lifecycle management of data collection, validation, reporting specification and usage guidelines.
- Understand CRF design and interpret protocol requirements to efficient EDC design.
- Create clinical databases design specifications including edit check specifications.
- Experience with validation of EDCs at a study level including experience developing study requirements, test scripts, and UAT documentation.
- Administration of existing EDC systems for multiple studies simultaneously.
- Provide clinical data management support for study operations and analysis groups including the following.
- Assist in defining and creation of data listings, including programming software to generate listings.
- Data specifications and/or process data transfers in preparation for statistical review.
- Training users on EDC systems. Includes create of training documentation and running training sessions for end users.
- Data cleaning and review of clinical data. Including query management and data listing review.
- Manage post-go live issues and requests.
- Managing activities for multiple studies simultaneously in a dynamic environment.
- Contribute to development and/or maintenance of departmental operating procedures for data management.
- Proactive in understanding company needs/priorities and able to autonomously seek solutions. Works on significant and unique issues in critical situations and able to provide solutions proactively.
Qualifications
Required Skills and Experience
- Minimum of 3-5 years of data management experience with a proven track record working in a medical device/pharmaceutical industry.
- EDC system(s) experience (Preferably Medrio)
- Knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
Required Education and Training
- Minimum BSc/BA in a scientific or medical field
Preferred Skills and Experience
- Desired to have experience with SAS software.
- Desired to have medical knowledge as pertaining to medical devices for surgery.
- Excellent Interpersonal skills
- Work well in a team environment.
- Work independently to carry out tasks with minimal guidance.
- Effective written communication and interpersonal skills.
Additional Information
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
