Manager/Senior Manager, Clinical Data
1 month ago
At Kumquat, we strive to develop life changing medicines in an efficient and innovative way with the shared mission of patient focus. The biometrics department plays an essential role in innovative clinical trial delivery and data quality to bring better clinical trials to more patients by improving the patient, caregiver and site experience.
We want you to join our mission and be part of our passionate and collaborative community, We value individual and team accountability and also see the potential of all our people to learn, grow, develop and achieve great things beyond the confines of traditional descriptions.
Clinical Data Manager:
Be able to function as a clinical data manager on small multiple studies with minimal guidance
Represent Data Management on the CTWG for assigned studies
Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts
Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
Perform a thoroughly detailed review of eCRF data requirements.
Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
Lead the development of data edit check specifications and data listings
Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members
Develop or lead the development of the Data Management Plan for a clinical study.
Review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
May provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed
Perform reconciliation of header data from external data sources against the clinical database
Perform Serious Adverse Event reconciliation activities
Lead database upgrades/migrations including performing User Acceptance Testing
Be able to maintain study workbooks and data management files
Perform database lock and freeze activities
Participate in regular team meetings and provide input when appropriate
Provide input into the development of data management SOPs, Work Instructions, and process documents
Assist with the training of new employees and/or contractors
Who you are:
You are a talented and passionate human, inspired by our shared purpose to innovate clinical trial delivery to bring better trials to more patients and generate quality data.
You are an effective communicator that shares information transparently and strategically. You are comfortable working out loud and are an active listener.
You thrive leading or being an active member of large or small diverse teams.
Requirements:At least five years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
Understands the scope and focus of Phase 1-3 clinical studies and has a proven ability to perform most of the core Data Management tasks and interact with vendors.
Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Possesses strong English language written and verbal communication skills.
Experience and understanding of the Oncology therapeutic area
Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.
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