At a Glance
- Tasks: Lead complex clinical data reviews and collaborate with top scientists in the field.
- Company: Join IQVIA, a global leader in clinical research and healthcare intelligence.
- Benefits: Flexible home-based work, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with a focus on innovation and continuous improvement in clinical data management.
- Why this job: Make a real impact in oncology and cardiovascular research while advancing your career.
- Qualifications: 5+ years in data management and expertise in eCRF systems required.
The predicted salary is between 36000 - 60000 £ per year.
Looking for a data management expert, who has prior experience in performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). Prior experience of closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team members when implementing the data management related activities for protocols, with focus on more complex indication and therapy related elements of the study. Has prior experience of being involved and driving discussions with SRP/SRS and collaborates with the Data management team to establish, align, and confirm scientific clinical data review expectations for assigned trial(s). Extensive prior experience of 5+ years supporting studies within the therapeutic area Oncology or CV&M. Rave experience mandatory.
Deliverables
- Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
- Provides scientific data review support for more than one low to moderate complexity trial or one high complexity trial.
- The data management expert who, within the therapeutic area, is performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).
- Tapping into technical and clinical expertise, closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team members when implementing the data management related activities for protocols, with focus on more complex indication and therapy related elements of the study.
- Reviews all necessary data flows, the Data Management Plans and performs continuous (complex) data review activities on the studies in the assigned program.
- Involved in study related activities from the protocol design stage onwards, providing input into the study specific and/or indication specific data collection tools.
- Reviews (complex) scientific study data, manages CDM and SRS/SRP related queries in EDC system.
- Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible.
- Leads and/or attends meetings as appropriate.
- Takes a leadership role with SRP/SRS and collaborates with the GDM to establish, align and confirm scientific clinical data review expectations for assigned trial(s).
- With the trial customer, CRO and other functional partners in relation to CDM related activities:
- Reviews content and integration requirements for eCRF and other data collection tools.
- Establishes conventions and quality expectations for clinical data.
- Sets timelines and follows up regularly to ensure delivery of all Clinical Data Management milestones.
- Creates the Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
- Reviews related clinical data management documents.
- Ensures compliance with regulatory guidelines and documentation requirements.
- Ensures real-time inspection readiness of all assigned deliverables for the trial; participates in Regulatory Agency inspection and Client internal audits as necessary.
- Plans and tracks applicable CDM deliverables.
- Ensures CDM deliverables are on time.
- Takes a leadership role in collaborating with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are met.
- Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
- Identifies and participates in process, system, and tool improvement initiatives within clinical data management.
Education/Experience
- BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with professional clinical experience/exposure.
- 5 years Data Management experience performing scientific (complex) clinical data review.
- Knowledge in medical terminology would be preferable.
- Must have experience in supporting the eCRF build.
- Rave knowledge and experience mandatory.
This role is not eligible for UK visa sponsorship.
Clinical Data Manager - homebased (FSP) employer: IQVIA
At IQVIA, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the field of clinical data management. Our home-based roles provide flexibility while ensuring that our employees have access to extensive growth opportunities, professional development, and the chance to contribute to meaningful projects in the therapeutic areas of Oncology, Cardiovascular, and Immunology. Join us to be part of a team that is dedicated to improving patient outcomes and advancing healthcare worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Data Manager - homebased (FSP)
✨Get Involved with Local Health Initiatives
Join local community health events or volunteer for organisations like public health agencies. This not only builds your experience but also helps you network with industry professionals who might know of openings at places like IQVIA.
✨Tap into Professional Associations
Check out associations like the Institute of Healthcare Management. They often have job boards, networking events, and conferences that are perfect for connecting with potential employers in health sciences administration.
✨Stay Updated with Industry Trends
Follow health policy news and trends—being knowledgeable about the current landscape will not only help you in interviews but also make you stand out as a candidate. You can discuss recent developments and their implications when chatting with folks at IQVIA.
✨Apply Through Our Website for Better Visibility
When you find roles that excite you, especially at places like IQVIA, don’t forget to apply through our website. This can sometimes give you an edge by showing the employer you’re savvy and committed to finding the right fit.
We think you need these skills to ace Clinical Data Manager - homebased (FSP)
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at IQVIA.
Showcase Your Administrative Skills:Administrative skills are key in this field, so don’t hold back! Make sure your CV reflects your proficiency in things like scheduling, data management, and compliance with health regulations. Mention specific software you’ve used, such as patient management systems, as this will demonstrate your hands-on abilities and readiness for the role at IQVIA.
Craft a Meaningful Cover Letter:Your cover letter should reflect your passion for the health sciences field and your eagerness to contribute to IQVIA. Share a bit about why you’re drawn to this sector, any impactful situations or challenges you’ve encountered, and how they’ve shaped your desire to work in health sciences administration. This personal touch can really set you apart!
Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at IQVIA. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at IQVIA
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
✨Prepare for Scenario Questions
Interviews for administrative roles often involve scenario-based questions to assess your problem-solving skills. Practice responses to common situations you might face, such as dealing with a challenging patient or managing a sudden schedule change. This will not only demonstrate your ability to think on your feet but also highlight your interpersonal skills.
✨Align Your Goals with the Organisation
As a full-time candidate, employers will want to know how your long-term career goals align with their mission. Take some time to research IQVIA’s values and be ready to tie your passion for health sciences administration into their objectives. Demonstrating enthusiasm and career alignment can be a game-changer in this competitive field!
