Our mission is to build software that saves lives. Our technology lowers the cost of clinical trials by streamlining data capture processes while providing a platform that protects patient privacy. ClinCapture advances the evaluation and development of drugs, biologics, and devices that demonstrate promise for the diagnosis and/or treatment of a wide range of diseases or medical conditions.
We are seeking a Project Manager with Clinical Data Management or EDC/study build experience to join our team.
- Provide Clinical data management support to Clinical Operations team and/or study project, Clinical Data Management team, and Biostatistics team.
- Participate in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports, and Statistical analysis).
- Develop Data Management Plan (DMP), maintain DMP throughout lifecycle of study project, and ensure DMP is followed according to study design and requirements.
- Develop Case Report Form (CRF), electronic and/or paper.
- Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations.
- Lead EDC database (DB) specification process.
- Create Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
- Reconcile electronic data transfers from vendor to Sponsor.
- Develop test scripts and execution logs for User Acceptance Testing (UAT).
- Coordination of UAT of eCRF build and validation documents, including but not limited to: edit check document, issue logs, UAT summary report.
- Maintenance/tracking of EDC user management and other Clinical databases across allocated Clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts.
- Provide training on study trial for EDC and create user guides.
- Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.
- Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
- Coordinate the archiving of study databases and related documents.
- Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
- Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding.
- Assist and provide input into study and project level data analysis plan.
- Coordinate and communicate with DB vendors on consistent basis to address Clinical team’s requests, project plans, and/or eCRF development activities.
- Collaborate with IT and implementation team(s) to address Clinical application requests and/or changes to Clinical database systems.
- Participate in the preparation and presentation of data, when applicable.
- Ensure data system compliance by following the established guidelines of national and international regulatory authorities.
- Participate in conference calls and/or meetings with vendors to report findings.
- Applicable knowledge working with clinical databases.
- Experience with working on Phase I- IV study trials within the medical device and/or pharmaceutical industry
- Excellent verbal and written skills, good organizational, interpersonal, and team skills
- Bachelor’s degree in a science related field or equivalent work experience
- 2 to 5 years data management and/or related industry experience or equivalent combination of experience and relevant higher education
- Working knowledge of Good Clinical Practices, Clinical research, and Clinical trial process
- Working knowledge of Clinical database applications such as EDC