Clinical Data Specialist Temporary contract 6 months

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 pioneer and leading company in the field of 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.

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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 Position:

The Clinical Data Specialist is principally responsible for building eCRF from end to end as well as analyzing complex clinical data sets to optimize workflow and to ensure that the data gathered is accurate and reliable within his/her assigned projects in the region covered by Clinical Affairs EMEIA.

Roles and Responsibilities:

• Build eCRF studies from end to end in Medidata Rave EDC including derivations, dynamics and edit checks
• Perform post production changes / Migration
• Coding custom functions with C# for Rave studies is a plus
• Assist in testing and evaluating new upgrades to technologies
• Conduct and coordinate the validation and testing (UAT) of the clinical database
• Clinical Data Reports: Develop scripts to produce study-specific clinical data status reports as required.
• Review clinical data on an ongoing basis to ensure compliance of data Integrity and quality control procedures.
• Liaise directly with Clinical Research Associate (CRA) to ensure data discrepancies are addressed in a timely manner.
• Act as point of contact for project manager, statistician and/or sites, regarding clinical data, data reporting needs and data analysis.
• Contribute to Data Management (DM) documents such as Data Management Plan (DMP), Data Validation Plan, Data Review Plan, annotated CRF, CRF Completion Guidelines to ensure standardization.
• Contribute during database vendor qualification and audit.
• Prepare presentations for colleagues and present clinical data status reports for both internal and external stakeholders.
• Work independently within projects and actively seeks to develop the role further to support Clinical Affairs projects.
• Assist in building departmental initiatives.
• Be responsible for support of multiple studies simultaneously in a dynamic environment.

Qualifications

Required Knowledge, Skills, and Experience:

• Bachelor’s degree with minimum 5 years’ experience in the clinical research field including 3+ years of relevant work experience in Data management.
• Experience working with medical data in a research environment.
• Should have experience in RAVE programming including study build/eCRF build, Edit checks validation, post production changes, Migration and various modules in RAVE programming.
• Excellent understanding of EDC and SAS listings.
• Strong knowledge and adherence to Good Clinical Practice (GCP) and other clinical affairs regulatory practices and laws and of clinical trial process, CRF design, Clinical database applications such as EDC and CTMS.
• Good understanding of data administration and management functions (collection, analysis, data review process, etc.).
• Proficient in the use of data management software and MS Office (Excel, PowerPoint, Word, etc.) and SAS software.
• Proven ability to working with multiple teams on multiple projects simultaneously.
• Demonstrated flexibility when prioritizing work and delivering on goals.
• Excellent analytical and problem-solving skills.
• Excellent written, verbal communication and presentation skills.
• Ability and willingness to travel 10% of the time, primarily via plane or train.
• Ability to work independently and in a team-oriented environment.
• English fluent.

Preferred Knowledge, Skills, and Experience:

• RAVE programming read, understand and program Medidata RAVE Edit checks and custom function from data validation specification.
• French and /or German a plus.

Additional Information

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.