Vacancy expired!
- This position has a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third party vendors.
- This position has strong verbal/written skills, analytical, organizational, and interpersonal skills and is able to work effectively with people at different levels and from different disciplines and cultures.
- Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements.
- This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry within one or more therapeutic areas.
- Finally, this position has moderate skills in continuous improvement, project management, change management, and risk management.
- Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studies
- Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting).
- Provides oversight for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
- Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable company and regulatory requirements.
- Reviews/approves clinical study related documents (e.g., Protocols, Data Management Plan, Clinical Study Reports).
- Leads and drives the data review process in collaboration with the study team to ensure data quality
- Participates in audits and inspections.
- Provides comprehensive data management expertise to project/study teams to optimize study-specific clinical trial processes.
- May participate in process improvement initiatives.
- BS/RN in life sciences or related field (or equivalent 3-6 years of experience)
- 3-6 years of data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO)
Vacancy expired!