Patient Data Specialist

We are seeking a Patient Data Specialist to join our team!

This is a remote-based opportunity with flexible location options in Hungary, Serbia, UK, Spain, Romania, Slovakia, or Poland.

At Precision for Medicine, we believe in advancing personalized medicine through innovative assays utilizing biomarkers to identify the right patient for the right drug. We handle all aspects of clinical trials, from strategy and design to site selection and execution.

Role Overview

The Patient Data Specialist should possess strong knowledge of medical and oncology standards relevant to clinical trials, preferably with expertise in hematologic malignancies. The role involves scientific review of clinical data, supporting data quality, and ensuring consistency to facilitate insights for risk management. A medical degree or related healthcare qualification (RN, OCN, RPH, PharmD, etc.) with hematology knowledge is preferred.

Key Responsibilities

1. Review subject data for accuracy according to protocol, references, and oncology standards to ensure data quality and consistency.
2. Develop and maintain collaborative relationships within internal and external teams, promoting our commitment to quality and ethics.
3. Support cross-functional communication regarding data capture and review trends, complying with GCP/ICH, protocols, and SOPs.
4. Contribute to project documentation, including EDC specifications and review guidelines, coordinating patient reviews across departments.
5. Assist in developing and testing data outputs, utilizing various EDC systems and visualization tools.
6. Provide scientific support and training to project teams, addressing data capture questions.
7. Identify and address data quality risks, recommending corrective actions.
8. Participate in UAT for programming outputs and support protocol reviews from a scientific perspective.
9. Review clinical trial data sources for consistency and accuracy, resolving queries in EDC systems.
10. Communicate findings effectively to team members and escalate issues as needed.
11. Contribute to study-specific training and monitoring tools.
12. Participate in project meetings, presenting data trends and issues.
13. Establish task tracking to monitor progress and provide project updates.
14. Ensure proper documentation and version control of eTMF records.
15. Perform other duties as assigned.

Qualifications - Minimum Required

• Bachelor’s degree or equivalent in science or healthcare, with proficiency in medical terminology.

Other Requirements

• Experience in oncology, with knowledge of hematologic malignancies preferred.
• At least 2 years in clinical operations, data management, or related fields, preferably in CRO or pharmaceutical industry, or relevant oncology research experience.
• Experience reviewing oncology clinical trial data and familiarity with standards like tumor response criteria and CTCAE.
• Experience with phase I-III oncology trials preferred.
• Proficiency with EDC systems, data visualization tools, and computer skills.
• Knowledge of FDA and ICH/GCP regulations.

Highly Preferred

• Medical-related degree (RN, OCN, RPH, PharmD, etc.)
• Hematologic malignancies expertise

Competencies and Skills

• Ability to work remotely with minimal supervision, applying oncology knowledge to data review.
• Understanding of oncology clinical trial methodology and standards.
• Continuous learner with a keen interest in oncology standards of care.
• Problem-solving, critical thinking, and attention to detail.
• Professional communication skills in English.
• Team-oriented with high motivation and independence.
• Quick learner of clinical and technical information.
• High emotional intelligence and proficiency in IT tools, including Microsoft Office, EDCs, EMRs, and data visualization.
• Willingness to travel domestically and internationally up to 25%.

Join us in revolutionizing cancer treatment through precision medicine, leveraging biomarkers, advanced technology, and targeted clinical trials to make a meaningful impact.