We are seeking Patient Data Specialist to join our team!
This is a remote based opportunity. We offer flexible location options and remote based working in one of the following countries: Hungary, Serbia, UK, Spain, Romania, Slovakia or Poland.
At Precision for Medicine, we believe that the era of one-size-fits-all medication is giving way to a next generation of treatments, medicines that will be more effective because they are prescribed according to the unique biology of an individual patient. Our mission is to help innovative biotech and pharmaceutical companies accelerate the development of these life-changing treatments. Precision does this by developing assays that utilize biomarkers to help identify the right patient for the right drug. We handle every aspect of clinical trials from initial strategy and design to selecting sites and executing quality clinical trials.
The Patient Data Specialist must have a strong working knowledge of medical and oncology standards applicable to clinical trials, preferably with a knowledge of hematologic malignancies, to perform early and continuing scientific review of clinical data in various formats by applying the protocol and/or other applicable references along with oncology standards for the indication being studied to support overall data quality and consistency (clinical sense of the data) allowing for insights to support a continuous risk management approach. A medical related degree, RN, OCN, RPH, PharmD, etc. with knowledge of hematologic malignancies is preferred.
Essential functions of the job include but are not limited to:
Serves on assigned project team(s) reviewing subject data for accuracy per protocol, associated references and oncology standards of care and principles to support overall data quality and consistency (clinical sense of the data)
Develops and maintains a good working relationship with internal and external project team members, serving as an ambassador to promote Precision's high quality and ethical image in accordance with the company Core Values
Collaborates with and is supported by management as well as the Medical Monitors to support cross functional departmental communication as applicable on data capture / review trends (e.g., Medical Monitoring, Safety, Clinical Operations, Project Management, Data Management, SAS Programming, Biostatistics, Translational Science, other vendors, etc.) to meet project deliverables in compliance with GCP/ICH, the protocol, oncology standards and applicable Project Plans and SOPs
Provides input into project related documentation such as EDC specifications and related completion guidelines, Data Review Guidelines, etc. and requires patient review to be coordinated and tracked with other departments as applicable (data management, medical, safety etc.).
Supports the development and User Acceptance Testing (UAT) of data outputs with Programming (e.g., Smart Patient Profiles, metrics/trackers, listings)
Requires the use of various EDC systems and data visualization tools
Assists Management by serving as a resource for project teams regarding scientific, clinical, oncology related questions supported by Medical Monitoring
Provides routine status updates on findings and escalates issues as appropriate with project team and Management
Assists with identification of quality risks and issues and recommends corrective action plans as needed to address deficiencies in performance throughout the life of the project
Conducts UAT of programming output and participates in EDC UAT supporting the functionality as applicable
Assists Management to provide review of the protocol from a scientific-operational perspective
May provide indication input into data capture and other clinical trial document development (e.g., EDC specifications, completion guidelines, edit checks, review guidelines, etc.)
Assists in the development and implementation of strategy for an integrated data cleaning process between all applicable departments (e.g., data management, medical, safety, vendors, sponsor, etc.)
Reviews and analyses clinical trial data sources early and ongoing throughout the trial to ensure consistency, integrity and accuracy based on project specific review guidelines with an emphasis on scientific and clinical sense (e.g., adherence to applicable disease assessment criteria).
Issues and resolves queries in various EDC systems
Communicates effectively with the internal and external project team as applicable and management to relay data quality issues/findings and implements necessary actions in response to those issues (e.g., CRA and/or site re-training)
Provides study-specific training for project teams to ensure accurate and consistent collection including re-training as applicable based on review findings
Develops applicable study-specific monitoring/CRA and data review tools as applicable
Participates as applicable in internal and external study-specific team meetings and presents data issues and/or trends as applicable
Serves as a resource to the project team for scientific questions regarding data capture
May review dictionary coding
Establishes task tracking metrics to monitor trial and team progress towards project goals
Provides routine Project Management updates at macro and micro level
Ensures applicable eTMF documentation related is provided and managed including version control of owned documents
Performs other duties as assigned by management
Qualifications:
Minimum Required:
Bachelor's degree or equivalent combination of education/experience in science or healthcare discipline with proficiency in medical terminology
Other Required:
Oncology therapeutic experience required, hematologic malignancy experience preferred, with ability to apply working knowledge (e.g., understanding of clinical and oncology standards of care and associated side effects, biomarkers, etc.) to data review.
At least two (2) years in clinical operations and/or, data management or related discipline in either the CRO or pharmaceutical industry and/or experience conducting oncology clinical research as a Study Coordinator, Research Nurse or related discipline, or equivalent, relevant experience and/or demonstrated competencies.
Experience in the review of data from oncology clinical trials with working knowledge of oncology standards (e.g., application of tumor response criteria, CTCAE criteria, etc.).
Experience in phase I, II and III oncology (hematologic and/or non-hematologic tumors) preferred.
Experience as a Clinical Research Associate (CRA) or Study Coordinator/Research Nurse preferred.
Experience with electronic data capture systems (EDC) and data visualization tools preferred
Computer proficiency
Working knowledge of FDA & ICH/GCP regulations and guidelines.
Highly Preferred:
Medical related degree, RN, OCN, RPH, PharmD, etc.
Knowledge with hematologic malignances
Competencies and Skills:
Expected to be able to work remotely with the ability to apply oncology and clinical trial knowledge to the review of subject data with minimal supervision.
Demonstrates a working knowledge of oncology with demonstrated ability to apply this knowledge to various tumor types and oncology standards of care (e.g. proficiency in the application of CTCAE, ASTCT, indication specific treatment guidelines, disease assessment criteria such as RECIST, iRECIST, RECIL, IWG, Lugano etc.)
Demonstrates the ability to understand oncology clinical trials methodology, including a working knowledge of protocols and specific indications being studied
Desire to continually learn and keep up to date on oncology standard of care
Resolves project related problems and prioritizes workload to meet deadlines with minimal support
Adaptable / Flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills
Proficient critical thinking, problem solving and decision making skills with attention to detail
Professional use of the English language in both written and oral formats
Demonstrates, an understanding of the service culture
Strong sense of teamwork
Exhibits high self-motivation, and is able to work and plan independently as well as be highly effective in a remote team environment
Ability to assimilate clinical and technical information quickly
Demonstrates a high level of emotional intelligence
Possesses practical knowledge of IT tools and systems including proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook, EDCs, EMRs and data visualization tools.
Values system and work ethic consistent with Precision Values and Company Principles.
Ability to drive and travel up to 25% domestically and internationally including overnight stays
Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.
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