Project Manager

Professional Services · San Francisco, California
Department Professional Services
Employment Type W2 - Full Time
Minimum Experience Experienced

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. 

Job Responsibilities:

  • 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, included 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.

Skills:

  • 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.

Requirements

  • MUST be willing to work from San Francisco office Monday - Friday
  • Bachelor’s degree in a science related field or equivalent work experience
  • 3 to 5 years data management and/or related industry experience or equivalent combination of experience and relevant higher education.
  • Experience in medical device or pharmaceutical industry/company.
  • Working knowledge of Good Clinical Practices, , Clinical research, and Clinical trial process
  • Working knowledge of Clinical database applications such as EDC

 

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  • Location
    San Francisco, California
  • Department
    Professional Services
  • Employment Type
    W2 - Full Time
  • Minimum Experience
    Experienced