we are a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality that utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death.
our company's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe, and Israel.
our company has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer, and other types of solid cancers.
We are looking for an experienced Manager, Clinical Data Quality Assurance to join the Real-World Evidence team.
The Manager, Clinical Data Quality Assurance will be responsible for the overall quality of clinical Real-World Data (RWD) as part of research projects to support and expand the application of TTFields technology.
The Manager, Clinical Data Quality Assurance will be dedicated to establishing and maintaining data quality assurance processes. Ensuring compliance with regulatory standards, and fostering cross-functional collaboration.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Overall monitoring of clinical real-world data quality.
Oversee external data vendors' activities related to data quality.
Develop data monitoring and quality control procedures.
Develop research-specific data monitoring documents.
Clinical review of medical coding.
Perform and oversee clinical data annotation and source data verification.
Validate the accuracy of automatic real-world data extraction from medical records.
Collaborate with internal and external stakeholders to support research activities.
Support research-specific quality audits and regulatory authority inspections, acting as a subject matter expert.
Requirements: Qualifications:
Bachelors degree in a related field (Medical Science, Life Sciences, Nursing) required.
A Masters degree in a related field is preferred.
Knowledge:
Minimum 6 years of experience in a CRA position (or similar) within the medical device, pharmaceutical, or biotech industry.
Lead CRA experience.
Experience in clinical trials or real-world data clinical research.
Experience in writing study monitoring documents
Solid tumor oncology experience is highly desired.
Knowledge of ICH GCP, CFR, and other relevant regulations and guidelines.
Fluency in English with excellent verbal and written communication skills, providing clear, concise, timely, and relevant information.
Able to efficiently understand and interpret large volumes of medical records.
Strong ability to identify and resolve complex challenges using critical thinking skills.
Excellent organizational and record-keeping skills with strong attention to detail, precision, and accuracy.
Ability to manage and prioritize multiple tasks simultaneously, proactively problem-solve, and manage competing priorities and deadlines.
Demonstrated ability to work well in a team as well as independently with limited oversight; self-motivated and results-driven.
This position is open to all candidates.