Senior Clinical Data Manager
Job Description
We are seeking a highly motivated Senior Clinical Data Manager to oversee and manage the data from our clinical trials. The Senior Clinical Data Manager will be responsible for managing the clinical data through the whole clinical trial, including the implementation and execution of clinical data capture, making sure of the accuracy and integrity of the data, cleaning and transferring clinical data in clinical studies. You will ensure that all data management activities are completed in accordance with GCP, regulatory requirements, and study-specific protocols. You will be a member of the Clinical Development Team working collaboratively to ensure the success of Freenome’s clinical studies. Additionally, You will work with other teams in Freenome to provide recommendations about how to use the clinical data.
Responsibilities
- Develop and maintain data management plans and procedures in accordance with GCP, regulatory requirements, and study-specific protocols.
- Ensure that all data management activities (including study data) is collected, processed, and stored in accordance with GCP, regulatory requirements, and study-specific protocols.
- Design the case report forms (CRFs) in collaboration with the medical and clinical operations according to clinical protocol and study data requirements. Ensure the eCRFs are properly built and rigorously tested through User Acceptance Testing (UAT).
- Serve as the domain expert in providing guidance to study teams on data management issues, including database design, CRF development, electronic data capture (EDC) system, and data cleaning.
- Develop and maintain data validation plans and perform ongoing data validation activities.
- Manage and execute data cleaning and query resolution activities to ensure that data is of high quality and accurate.
- Develop and maintain relationships with key stakeholders, including study sites, CROs, and other vendors.
- Partner with cross-functional team leads and stakeholders to generate datasets for analysis and reporting.
Job Requirements
- Bachelors or higher education in science (biological or computer) and/or clinical informatics related disciplines and at least five (5) years industry clinical data management experience.
- Strong experience with multiple EDC systems (Medio, RedCapCloud, or similar) including implementing and testing.
- Good knowledge of GPC, ICH guidelines, regulatory requirements and guidelines related to clinical data management.
- Experience in CRO communications, oversight, and management by working effectively both in a core team and functional team settings.
- Excellent problem-solving and critical-thinking skills.
- Strong business acumen and ability to work effectively across a multi-disciplinary team.
Nice to haves:
- Programming and data analysis experience.
