Reports To: Vice President, Biometrics
Position Type: Salaried, negotiable according to experience and fit; package includes company stock options, as well as tax advantaged employee benefit plans.
Tocagen is a clinical-stage, cancer-selective gene therapy company focused on developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer from within.
Every member of our team plays a significant role in our success. Tocagen hires individuals who share our passion for ending cancer mortality and have exceptional talent that will contribute to this goal.
The Associate Director, Clinical Data Management will be responsible for managing data collection, CRF designs, timeline planning, data review, and the review and quality control checks of study data and database design. The responsibilities of this position include being involved with coordinating activities with other functional groups to ensure timelines and quality of project deliverables, and to update and maintain SOPs to ensure the validity of clinical trials databases and are familiar with the implementation of Good Clinical Practice (GCP). In collaboration with other functions, this position establishes protocol-specific data review and entry guidelines to document data validation and formatting procedures, monitors timely data entry, reviews data discrepancies resolutions provided by the investigative sites and is familiar with database management systems; the principles and organizations to ensure that incoming CRFs are tracked in a timely manner prior to various reviews.
Duties and Responsibilities Include But Are Not Limited To:
- Reviews protocols for proper data capture including Case Report Form design; able to perform a thoroughly detailed review of CRF data requirements.
- Develops a Data Management Plan that outlines CRF flow, data queries, manual and computer edit checks, and data listings needed to facilitate Data Management activities throughout a clinical study.
- Leads and coordinates the design and testing of clinical study databases to match eCRF/CRFs protocol specifications; able to resolve database issues with team members.
- Oversees the setup databases for individual study protocols.
- Ability to provide data listings as required.
- Generates data query forms to be resolved at investigational sites.
- Performs database lock and freeze activities per company SOPs.
- Performs Serious Adverse Event reconciliation activities according to SOPs and guidelines.
- Provides guidance and monitors the progress of data management activities with CROs or other vendors.
- Ability to present clinical study CRFs and CRF completion instructions at investigator meetings and other trainings as needed.
- Participates in regular team meetings and provide input when appropriate.
- Provides input into the development of data management SOPs and processes; ability to write or review Data Management work instructions and SOPs.
- Interacts with CRAs, programmers, study managers and statisticians in overseeing the creation of a clinical study database, performs data quality assurance activities, and manages the resolution of data queries.
- Assists in database upgrades/migrations including performing User Acceptance Tests.
- Managing data quality reports.
- Performs other duties as required.
Desired Knowledge and Abilities:
- Service oriented approach, flexible and proactive towards changing needs.
- Working knowledge of current EDC technologies.
- Proficint with the development of eCRF/CRF for clinical trials and its impact into database design/development.
- Excellent verbal and written communication skills.
- Work precisely according to procedures, rules and regulations.
- Must possess a general knowledge of applicable clinical research regulatory requirements; including GCP and ICH guidelines.
- Strong Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
- Knowledge of electronic documentation management systems and publishing software a plus.
Education & Experience:
- BA/BS with 8-15 years of experience in clinical data management.
- MS with 5-10 years of experience working in large CRO/pharmaceutical or small biotech company.