![ICON Strategic Solutions](https://media.trabajo.org/img/noimg.jpg)
Medical Data Reviewer
7 days ago
Serve as a Clinical Data reviewer and identify any errors in data by performing data review that require further clarification with the study site. Perform ongoing review of clinical/medical aspects of assigned patient data and documents (escalates to Client Clinical Scientist and/or medical monitor, as appropriate)
Examples include but not limited to: Patient eligibility, diagnosis, medical history and prior treatments, study drug administration, AE/SAE/AESI, con meds, safety labs, efficacy assessments, EOT, EOS, survival, coding, etc. Issues clinical data queries and ensure timely follow up following site responses as to whether the queries are appropriately addressed, and updates in EDC done, if
applicable, by either closing out the queries or re-querying, as applicable
Communicates any data training needs for CRAs, sites, etc.
Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol
compliance and targeted review of patient data)
Provide clinical data Project Management and viewed as an expert in data clinical/medical
review and cleaning.
Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance.
May assist in review and contribute to data capture requirements guidance in line with protocol and reporting requirements.
Monitor site data entry performance and provide leadership to identify root causes of data issues and implement remedial actions.
Ensure timely follow-up and resolution of data related compliance issues.
Continuously assess opportunities to improve efficiency of tasks and quality of data deliverables. May contribute to EDC completion training.
May participate in clinical data review meetings such as:
o Protocol Deviation review
o Data Review and Quality Team (DRQT)
o Statistical Review of Clinical Data (SRCD)
o Safety Monitoring Team (SMT) review
o Slide preparation of top-line results
May be involved in preparing or review material for and presents in data dissemination meetings, such as:
- Investigator meetings, advisory boards, safety cohort review meetings, IDMC, SC, senior management meetings, central imaging review, CST/SPT/DPR/PRC discussions for study/program decisions
- May be involved in review and QC clinical data sections for abstracts / manuscripts/ oral and poster presentations
- Will collaborate closely with Client Clinical Scientists, Medical Directors, Data Management and Clinical Operations to execute clinical data reviews and activities prior to data cuts for snapshots, interim analysis, DSUR, IBs, regulatory requests, study site close-outs and final DBL.
- May be closely involved in data review and identification of readiness for clinical narratives for Clinical Study Report (CSR)
- May be involved in QC review of patient narratives and contribute to tracking of such.
Required Experience and Skill Set:
- Educational scientific background such as MD, PharmD, PhD, Nursing degree, MSc
- ≥ 5 years of pharmaceutical clinical/medical data review experience is required, including clinical crosscheck experience. 8+ years is preferrable.
- Experience with Solid Tumor Oncology
- Excellent verbal and writing communication in English, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
- Detail oriented
- Experience in coding review
- Query writing training
- Strong clinical database navigation skills
- Strong MS excel, project management
- Proven ability to work independently and in a team setting.
- Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON:
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
-
Medical Data Reviewer
7 days ago
Bengaluru, Karnataka, India ICON Strategic Solutions Full timeServe as a Clinical Data reviewer and identify any errors in data by performing data review that require further clarification with the study site. Perform ongoing review of clinical/medical aspects of assigned patient data and documents (escalates to Client Clinical Scientist and/or medical monitor, as appropriate) Examples include but not limited to:...
-
Medical Data Reviewer
1 week ago
Bengaluru, Karnataka, India ICON Strategic Solutions Full timeServe as a Clinical Data reviewer and identify any errors in data by performing data review that require further clarification with the study site. Perform ongoing review of clinical/medical aspects of assigned patient data and documents (escalates to Client Clinical Scientist and/or medical monitor, as appropriate)Examples include but not limited to:...
-
Medical Reviewer
7 days ago
Bengaluru, Karnataka, India Novo Nordisk Full timeDepartment - Centralised Monitoring Unit (CMU) Bangalore**About the departmentThe Centralised Monitoring Unit (CMU) Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers...
-
Medical Reviewer
7 days ago
Bengaluru, Karnataka, India Novo Nordisk Full timeMedical ReviewerCategory:Clinical DevelopmentLocation:Bangalore, Karnataka, IN**Department - Centralised Monitoring Unit (CMU) BangaloreAbout the department The Centralised Monitoring Unit (CMU) Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers) and technical...
-
18352-medical Data Reviewer
1 week ago
Bengaluru, Karnataka, India IQVIA Full timeJob OverviewReview structured clinical patient data output without direct access to medical charts to ensure medical plausibility and to determine adherence to protocol and overall completeness and readiness of the supplied patient information for next level of review.Essential Functions Identify any anomalies in patient reported data that require further...
-
Senior Medical Reviewer
1 week ago
Bengaluru, Karnataka, India Novo Nordisk AS Full timeDepartment – Centralised Monitoring Unit (CMU) Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we...
-
Senior Medical Reviewer
7 days ago
Bengaluru, Karnataka, India Novo Nordisk Full timeKey Responsibilities in this position will be to perform a Medical Review of all trial subjects of all assigned clinical trials within the drug development portfolio across therapy areas & to ensure high-quality quality consistent medical data. Medical Review is performed for all trial subjects to ensure patient safety and adherence to protocols, Good...
-
41263 - Mgr, Medical Data Review
7 days ago
Bengaluru, Karnataka, India IQVIA Full timeJob Overview Provide expert skills as part of a Medical Data Review team to deliver efficient, quality Medical Data Review products Offer Project management to the team in the area of clinical data review and recognized as an expert in data management Drive the delivery of end-to-end study data quality and integrity Offer medical, clinical, and scientific...
-
Bengaluru, Karnataka, India Lilly Full timeWe're looking for people who are determined to make life better for people around the world. LCCI Quality Medical Reviewer – Medical Affairs Quality (Title/level may vary by site or geographic location) Purpose: Organization Background Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate...
-
41599-pharmacovigilance-medical Review
7 days ago
Bengaluru, Karnataka, India HyreFox Consultants Full timeRoles and Responsibilities- o Review and verification of appropriate sections of adverse events, appropriate MedDRA coding, labelling, causality and provide a medical assessment comment as needed for ICSR.- o Reviews medical content and quality of the Case and ensures that all events from the source documents are accurately coded and verify consistency...
-
External Data Reviewer
7 days ago
Bengaluru, Karnataka, India Labcorp Full timeEssential Job Duties: Ensure electronic vendor data contains all protocol specified parameters, is in correct format and data populates to the specified fields and patients correctly May support LDM in the development of the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers. Review data discrepancies generated by study...
-
Curation Screening Reviewer
1 week ago
Bengaluru, Karnataka, India ConcertAI Full time**Work ExperiencePOSITION TITLE: Curation Screening ReviewerDIVISION:CPI Curation OfficeDEPARTMENT: QualityLOCATION:REPORTS TO:FLSA:Non-ExemptJOB STATUS:Full TimeAbout ConcertAIConcertAI is the leading provider of precision oncology solutions for biopharma and healthcare, leveraging the largest collection of research-grade Real-world Data and the only...
-
External Data Reviewer(4 to 8 Years)
7 days ago
Bengaluru, Karnataka, India Labcorp Full timeEssential Job Duties: Ensure electronic vendor data contains all protocol specified parameters, is in correct format and data populates to the specified fields and patients correctly May support LDM in the development of the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers. Review data discrepancies generated by study...
-
Associate Eds Reviewer
7 days ago
Bengaluru, Karnataka, India Labcorp Full timeEssential Job Duties: Follow applicable departmental Standard Operating Procedures and Work Instructions. Complete required trainings according to timelines. Review and action queries on an ongoing basis and update database appropriately in accordance with Global Data Management Plans and applicable standardized data management. Perform UAT according to...
-
Content Review Practitioner
7 days ago
Bengaluru, Karnataka, India Quess IT Staffing Full timeAbout Us"Quess IT Staffing is India's largest IT staffing company with over 20 years of experience in staffing IT professionals in 300+ companies across levels and skillsets. Our 10,000+ associates deployed in 80+ cities and towns are proficient in over 500 technological skills. Our associates help enable cutting edge solutions some of the biggest names...
-
Medical Transcriptionist
7 days ago
Bengaluru, Karnataka, India Lead Training and Corporate Solutions Full time*Producing medical reports and records, correspondence for Physicians, patient information and other administrative material such as statistics and patient data *Reviewing and editing transcriptions for spelling, grammar, clarity and correct medical terminology *Maintaining medical files and databases for various records such as medical historiesInterested...
-
Assoc Eds Reviewer
7 days ago
Bengaluru, Karnataka, India Labcorp Full timeEssential Job Duties:Follow applicable departmental Standard Operating Procedures and Work Instructions.Complete required trainings according to timelines.Review and action queries on an ongoing basis and update database appropriately in accordance with Global Data Management Plans and applicable standardized data management.Perform UAT according to...
-
Medical Affairs – Medical Writing
7 days ago
Bengaluru, Karnataka, India Lilly Full timeWe're looking for people who are determined to make life better for people around the world. Purpose: Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the...
-
Associate Eds Reviewer
7 days ago
Bengaluru, Karnataka, India Labcorp Full timeJOB DESCRIPTION:Ensure electronic lab data contains all protocol specifiedlab parameters, is in correct format and data populates to the specified fields and patients correctly. Review data discrepancies generated by study specific edit checks for laboratory data and assist in preparation of data clarification forms sent to the site or the central lab. Also,...
-
Medical Coder
1 week ago
Bengaluru, Karnataka, India UnitedHealth Group Full timeJob Family DescriptionPositions in this family include those reposnsible for functions in areas such as health services, clinical services and delivery of clinical careJob Function DescriptionJobs in this function provide coding and coding auditing services directly to providers. This includes the analysis and translation of medical and clinical diagnoses,...