The CDM will perform scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).
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 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:
o Reviews content and integration requirements for eCRF and other data collection tools
o Establishes conventions and quality expectations for clinical data.
o Set timelines and follow‐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; participate 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.
Therapeutic Area - Oncology, Cardiovascular and Immunology
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. 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.
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