Reports To: Associate Director, Clinical Data Management
Position Type: Contract position
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.
The Senior Clinical Data Manager oversees all clinical data management activities for the entire life cycle of one or more complex clinical trials, from protocol concept review through completion of the Clinical Study Report (CSR). As a member of the Study Management Team this role works with internal functional groups and CROs in coordinating study start up, maintenance and database lock activities to ensure timelines and quality of project deliverables are met. The Senior CDM participates in special initiatives both inside and outside the Data Management department such as SOP development and mentoring of less experienced staff.
Duties and Responsibilities Include But Are Not Limited To:
- Provides guidance and monitors the execution of all study CDM activities both internally and with the data management CROs or other vendors.
- Core member of Study Management Team (SMT).
- Primary CDM contact for SMT and CROs.
- Develop and maintain timeline for CDM study activities.
- Generate and/or review CDM metric reports and provide appropriate feedback to SMT.
- Participate in protocol development.
- Work with CRO to develop Data Management Plan that meets/exceeds Tocagen’s standards for data management activities.
- Coordinate CRF design, development, review and sign-off.
- Coordinate CRF Completion Guidelines, development, review and sign-off.
- Coordinate Data Review Guidelines (DRG) development, review and sign-off.
- Oversee/Guide development and review of CRF Completion Guidelines (CCGs).
- Review and sign-off Central Lab Specifications.
- Testing and acceptance of Clinical Database.
- Testing and acceptance of programmed edit checks.
- Communication to internal and external team of trends in data and CRF completion, e.g., common errors or poor performance at a site.
- Oversee CROs Execution of all data review guidelines (those programmed in EDC system, SAS, and manual review) and query management.
- Leads internal data review activities (Data Listing Reviews/Patient Profiles/etc.).
- Oversee or perform reconciliation of specialty lab data with clinical trial database.
- Oversee CRO medical coding of clinical data and facilitate medical review/approval.
- Oversee or perform Serious Adverse Events (SAEs) Reconciliation with clinical trial database.
- Oversee database lock process, ensuring compliance with CDM SOPs/Guidelines.
- Ensure that CDM responsible portions of the Trial Master File (TMF) are completed and posted.
- Review Clinical Study Report (CSR) and author or confirm the data quality section of CSR.
- Oversee/Coordinate reconciliation of treatment assignments or randomization’s with pharmacy data.
- Review subset of patient data and queries issued by CRO to ensure appropriateness and assess correctness of programmed edit checks.
- Presents clinical study CRFs and CRF completion instructions at investigator meetings and other trainings as needed.
- Provides input into the development of data management SOPs and processes; ability to write or review Data Management work instructions and SOPs.
- Mentors less experienced staff.
- Performs other duties as required.
Desired Knowledge and Abilities:
- Service oriented approach, flexible and proactive towards changing needs.
- Internal customer management, influence of peers, team effectiveness and enhancement, timeline management, proactive problem solving ability, resource planning, ability to develop trust, shared goals and values.
- Experience and firm understanding of at least one clinical data management system (e.g. InForm, Rave, Medrio, Merge eClinical).
- Proficint with the development of eCRF/CRF and thorough knowledge of CDASH and SDTM implementation.
- Excellent verbal and written communication skills.
- 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 in Life Sciences with 4-6 years of experience working in large CRO/pharmaceutical or small biotech company.
- MS with 2-3 years of experience working in large CRO/pharmaceutical or small biotech company.
- CRO oversite experience from the sponsor side.
- Experience or training in CDASH and SDTM.
- Good organizational and documentation skills.
- Team player who works effectively with other disciplines.
- A general understanding of regulatory guidance’s and regulations (e.g. ICH, 21CRFpart11, etc.).