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Precision Medicine Group

Patient Data Specialist

Full-Time 36000 - 60000 £ / year (est.) No home office possible

At a Glance

Tasks: Join our team as a Patient Data Specialist, reviewing clinical data for accuracy and quality.
Company: Precision for Medicine accelerates innovative treatments through advanced clinical trial strategies.
Benefits: Enjoy remote work flexibility and a supportive team culture across multiple European countries.
Why this job: Make a real impact in oncology research while working with cutting-edge technology and passionate professionals.
Qualifications: A medical-related degree and experience in oncology clinical trials are preferred.
Other info: This role offers opportunities for continuous learning and professional growth in a dynamic environment.

The predicted salary is between 36000 - 60000 £ per year.

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.

#LI-NC1 #LI-Remote

Patient Data Specialist employer: Precision Medicine Group

At Precision for Medicine, we pride ourselves on being an exceptional employer that champions innovation and collaboration in the field of oncology. Our remote work culture allows for flexibility across various European locations, fostering a supportive environment where employees can thrive and grow professionally. With a commitment to continuous learning and development, we empower our Patient Data Specialists to make meaningful contributions to life-changing treatments while enjoying a strong sense of community and shared purpose.

Contact Detail:

Precision Medicine Group Recruiting Team

View Precision Medicine Group Profile

StudySmarter Expert Advice 🤫

We think this is how you could land Patient Data Specialist

✨Tip Number 1

Familiarise yourself with the latest oncology standards and guidelines, especially those related to hematologic malignancies. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.

✨Tip Number 2

Network with professionals in the clinical trials and oncology sectors. Attend relevant webinars or conferences to connect with potential colleagues and learn more about the industry trends, which can give you an edge during discussions with our team.

✨Tip Number 3

Prepare to discuss specific examples from your past experience where you successfully managed data quality or resolved issues in clinical trials. Being able to articulate these experiences clearly will showcase your problem-solving skills and expertise.

✨Tip Number 4

Demonstrate your adaptability and remote working skills during the interview process. Share instances where you've effectively collaborated with teams remotely, as this role requires strong communication and teamwork in a virtual environment.

We think you need these skills to ace Patient Data Specialist

Strong knowledge of medical and oncology standards

Experience with hematologic malignancies

Clinical data review skills

Understanding of clinical trial protocols

Proficiency in electronic data capture (EDC) systems

Familiarity with FDA & ICH/GCP regulations

Data analysis and interpretation skills

Excellent communication skills

Ability to work independently in a remote environment

Critical thinking and problem-solving abilities

Attention to detail

Team collaboration skills

Adaptability to changing priorities

Proficient in Microsoft Office Suite

Experience in project management

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights relevant experience in clinical operations, data management, and oncology. Emphasise any specific roles or projects that relate to hematologic malignancies or oncology clinical trials.

Craft a Compelling Cover Letter: In your cover letter, express your passion for precision medicine and how your background aligns with the company's mission. Mention specific skills or experiences that demonstrate your ability to contribute to the role of Patient Data Specialist.

Highlight Relevant Qualifications: Clearly outline your educational background and any medical-related degrees you possess. If you have certifications like RN, OCN, or PharmD, make sure these are prominently featured as they are highly preferred for this position.

Showcase Your Technical Skills: Detail your proficiency with electronic data capture systems (EDC) and any data visualisation tools you've used. Mention your familiarity with FDA & ICH/GCP regulations, as this is crucial for the role.

How to prepare for a job interview at Precision Medicine Group

✨Know Your Oncology Standards

Make sure you brush up on the latest oncology standards and guidelines, especially those related to hematologic malignancies. Being able to discuss these confidently will show your expertise and understanding of the field.

✨Demonstrate Data Review Skills

Prepare to discuss your experience with data review in clinical trials. Be ready to provide examples of how you've ensured data quality and consistency in past roles, as this is crucial for the Patient Data Specialist position.

✨Showcase Your Teamwork Abilities

Since collaboration is key in this role, think of specific instances where you've worked effectively within a team. Highlight how you communicated with different departments to achieve project goals.

✨Ask Insightful Questions

Prepare thoughtful questions about the company's approach to precision medicine and their current projects. This not only shows your interest but also your proactive attitude towards understanding their mission and values.

Patient Data Specialist

Precision Medicine Group

Patient Data Specialist

At a Glance

Patient Data Specialist employer: Precision Medicine Group

StudySmarter Expert Advice 🤫

✨Tip Number 1

✨Tip Number 2

✨Tip Number 3

✨Tip Number 4

We think you need these skills to ace Patient Data Specialist

Some tips for your application 🫡

How to prepare for a job interview at Precision Medicine Group

Patient Data Specialist

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