The Clinical Trials Project Manager will develop, implement and manage all aspects of clinical trials in domestic and international countries for our clients. In addition, the Clinical Trials Project Manager will provide training to clients and internal staff. This is a full-time position.
- Responsible for all data management tasks from study start-up through database lock. This includes database design, development of data management documents, and development of CRFs/eCRFs.
- Meet internal and external (Sponsor) deadlines and requirements according to time, quality, scope, and budget parameters.
- Ensures all data is accurate by programming edit checks, data cleaning, and generating and managing queries.
- Provide training support to clients and study staff on Electronic Data Capture (EDC) usage.
- Partner with the other functional groups (e.g., Biostatistics, Statistical Programming, Medical Writing, etc.) to ensure data management aspects of the project are properly considered and integrate well with the other activities
- Support the team with ongoing project work, as determined by business need
- Experience in project management roles, particularly in clinical data management, operations or project leadership role
- Up to 10% travel may be required.
- Develop and/or review case report forms (CRFs) within EDC system.
- Author SOPs and WIs related to data management activities and the needs of the client, including the Data Management Plan, Data Transfer Plan, and Data Validation Plan.
- Lead all data cleaning activities, including data review and query generation and management.
- Aid in SAE reconciliation and reconciliation of external data (e.g. Core Lab).
- Ensure all medical coding is performed in a timely manner.
- Lead all database lock activities.
- Maintain close working relationship with software vendor.
- Build study database, program queries and edit checks.
- Liaise between study personnel and the client, as appropriate, regarding clinical and/or technical issues.
- Provide training support to clients and study staff on EDC usage.
Data Reporting and Analysis
- Produce study status reports, data tables, listings, or other outputs as required throughout the course of the project.
- Work with the Biostatistician in development of the Statistical Analysis Plan.
Education & Professional Experience:
- Bachelor’s Degree or higher in a related field, such as clinical/science fields
- Three (+) years of professional experience in clinical data management best practices, managing, cleaning and integrating large, complex databases and in health information systems and informatics standards
- 3 – 5 years’ experience in Health Data Analysis/Management, Statistics, FDA regulation clinical studies, and/or Public Health (Epidemiology/Biostatistics Focus) a plus.
- Excellent interpersonal, communication, and organizational skills with the ability to work both independently and in a team environment.
- Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
- Strong working technical skills, including Microsoft Office, EDC platforms, and programming languages. Ability to learn new applications.
Interested? Send your resume with the position of interest in the subject to email@example.com