Senior Clinical Data Manager
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Job Location:
Durham, NC - USA
Monthly Salary:
$ 86800 - 217100
Posted on:
19 days ago
Vacancies:
1 Vacancy
Job Summary
Function: Integrated Data Analytics & Reporting
Clinical Data Management Expertise. The CDM will perform scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).
Base Level:
- Services rendered will adhere to applicable Clients 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 and holds discussions with SRS/SRP. 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:
- 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 realtime inspection readiness of all assigned deliverables for the trial; participate in Regulatory Agency inspection and clients 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.
Education and Experience Requirements/Qualifications:
- 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. Leadership experience.
- Data Management experience preferably including clinical data review or significant experience with clinical data review. Knowledge in medical terminology would be preferable
- Collaboration with Clinical teams.
- Experience in clinical drug development within the pharmaceutical industry or related industry.
- College graduate: Data management experience or clinical data review.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. potential base pay range for this role when annualized is $86800.00 - $217100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge skills education and experience; location; and/or schedule (full or part-time). Dependent on the position offered incentive plans bonuses and/or other forms of compensation may be offered in addition to a range of health and welfare and/or other benefits.
Required Experience:
Manager
Key Skills
- SQL
- Data Collection
- GCP
- Master Data Management
- R
- Data Management
- Clinical Trials
- User Acceptance Testing
- Data Warehouse
- SAS
- Oracle
- Data Analysis Skills
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
