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Patient Information Quality Coordinator

hace 3 meses

Alcobendas, Madrid, España Precision Medicine Group A tiempo completo

Join Our Team as a Patient Data Specialist

This position offers the flexibility of remote work, allowing you to operate from various locations including Hungary, Serbia, the UK, Spain, Romania, Slovakia, or Poland.

At Precision Medicine Group, we are committed to transforming the landscape of healthcare by moving towards personalized treatment options. Our objective is to assist pioneering biotech and pharmaceutical organizations in expediting the development of groundbreaking therapies. We achieve this by creating assays that leverage biomarkers to pinpoint the ideal patient for specific medications. Our comprehensive approach encompasses all facets of clinical trials, from initial strategy formulation and design to site selection and execution of high-quality clinical studies.

The Patient Data Specialist is expected to possess a robust understanding of medical and oncology standards relevant to clinical trials, with a preference for expertise in hematologic malignancies. This role involves conducting both preliminary and ongoing scientific evaluations of clinical data across various formats, ensuring adherence to protocols and oncology standards to uphold data quality and consistency. A medical-related degree, such as RN, OCN, RPH, or PharmD, along with knowledge of hematologic malignancies, is highly desirable.

Key Responsibilities:

  • Participate in designated project teams to verify subject data accuracy in accordance with protocols and oncology care standards, ensuring overall data integrity.
  • Foster and maintain positive relationships with both internal and external project team members, acting as a representative of Precision's commitment to quality and ethical standards.
  • Collaborate with management and Medical Monitors to facilitate effective communication across departments regarding data capture and review trends.
  • Contribute to project documentation, including EDC specifications and data review guidelines, ensuring coordination with relevant departments.
  • Support the development and User Acceptance Testing (UAT) of data outputs in collaboration with Programming teams.
  • Utilize various EDC systems and data visualization tools as part of the role.
  • Serve as a resource for project teams on scientific and clinical inquiries related to oncology.
  • Provide regular updates on findings and escalate issues to project teams and management as necessary.
  • Identify quality risks and propose corrective action plans to address performance deficiencies throughout the project lifecycle.
  • Conduct UAT for programming outputs and assist in EDC UAT to ensure functionality.
  • Review protocols from a scientific-operational viewpoint and provide input into data capture strategies.
  • Assist in the formulation and execution of an integrated data cleaning strategy across all relevant departments.
  • Continuously review and analyze clinical trial data to ensure consistency and accuracy based on established guidelines.
  • Communicate effectively with project teams and management regarding data quality issues and implement necessary corrective actions.
  • Deliver study-specific training to project teams to ensure accurate data collection.
  • Develop monitoring tools and participate in study-specific meetings to present data issues.
  • Establish task tracking metrics to monitor project progress and provide routine updates.
  • Ensure proper management of eTMF documentation and version control.
  • Perform additional duties as assigned by management.

Qualifications:

Minimum Requirements:

  • Bachelor's degree or equivalent experience in a science or healthcare discipline with a strong grasp of medical terminology.

Other Requirements:

  • Experience in oncology therapeutics is essential, with a preference for hematologic malignancy expertise.
  • A minimum of two years in clinical operations, data management, or a related field within the CRO or pharmaceutical industry.
  • Familiarity with oncology clinical trial data review and standards.
  • Experience with electronic data capture systems and data visualization tools is preferred.
  • Proficient in FDA & ICH/GCP regulations and guidelines.

Highly Preferred:

  • Medical-related degree such as RN, OCN, RPH, or PharmD.
  • Knowledge of hematologic malignancies.

Competencies and Skills:

  • Ability to work independently in a remote environment while applying oncology knowledge to data review.
  • Strong understanding of oncology clinical trial methodologies and protocols.
  • Desire for continuous learning and staying updated on oncology standards of care.
  • Effective problem-solving and decision-making skills with attention to detail.
  • Proficient in Microsoft Office and other IT tools.
  • Strong teamwork and interpersonal skills.

At Precision Medicine Group, we are dedicated to advancing cancer treatment through innovative methodologies and a commitment to excellence.