Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.
A Clinical Data Manager (CDM) is responsible for the Data review, User Account Management, QC activities and other data review tasks for a clinical study.
- Follow Standard Operating Procedures (SOPs).
- Perform DM Review.
- Review eCRFs in the clinical database to ensure data is consistent and complete utilizing the DMP and ECS.
- Perform manual review as listed in the ECS.
- Identify data discrepancies outside of the ECS and communicate manual queries where necessary to applicable data management personnel.
- Perform Vendor Data Reconciliation with applicable clinical database (e.g. IVRS, laboratory data, SAE).
- Identify potential queries and communicate findings to applicable personnel.
- Address answered queries, identify any re-queries needed, and communicate to applicable data management personnel.
- Track all DM issues and ensure proper resolution by study completion.
- Identify data trends and report inconsistencies to applicable data management personnel and work together to develop and implement an action plan.
- Identify the achievement of milestones and report to the applicable data management personnel.
- Perform User Account Management.
- Perform data entry or quality control review of Laboratory Normal Ranges
- Perform archival of study data from EDC system.
- Additional responsibilities
- May Perform 1 st and 2 nd pass entry following the DMP and client conventions, if applicable.
- Assist in the creation and review of SOPs and training materials.
- Ad hoc report creation.
- Conduct training for employees.
- Perform other duties as requested by management.
Minimum Training Requirements
The list below includes the general training subjects, and not necessarily the exact name of the training course obtained:
- Applicable Standard Operating Procedures
- Good Clinical Practices (GCP Regulations' ICH Guidelines; Good Quality Practices)
- 21 CFR Par 11 and Computer Security (Part 11, Electronic Records; Electron Signature-Scope and Applications; 21 CFR 11 and Industry Guidance's; Computerized Systems Used in Clinical Trials)
- Good Clinical Data Management Practices
- Drug Development and Approval Process
- Data Management Overview
- MedDRA and WHODRUG Overview
- Sponsor/Study specific trainings, when applicable
- Applicable system training
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