At DICE Therapeutics, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.
In this role you must have a keen eye to detail and a proactive, positive, collaborative mindset. You will be a key contributor in ensuring DICE Trial Master Files (TMFs) are of the highest quality and completeness and play an essential role in ensuring DICE TMFs are ready for regulatory or internal inspections. In addition, you will guide and support cross-functional teams in performing their responsibilities in relation to the document filing and management, ensuring clinical study documents are filled, reviewed and managed in accordance with DICE Standard Operating Procedures (SOPs), good clinical practice, applicable regulatory guidelines and meet all quality and timeline metrics.
- Serve as a clinical research Records Management Subject Mater Expert to drive coordination across project teams internally and externally to ensure TMFs are set-up and maintained in accordance with DICE’s SOPs and Work Instructions.
- Support deliverables related to the TMF as outlined in the study-specific TMF Plan, including performing an independent review and approval of all study-, country- and site-level documents within agreed timelines.
- Monitor overall quality and completeness of the TMF, from start-up to archival, working closely with CRO partners to ensure all study related documents are accurately processed in the TMF and in a timely manner.
- Drives day-to-day management and procurement of expected artifacts; performs metadata checks /missing items assessments.
- Maintains internal document repositories, including study setup, access, etc.
- Coordinate, support and monitor cross-functional team members in filing and maintaining the TMF, and in performing required cross-functional review and QC activities.
- Track and communicate TMF /document management trends and issues to the Study Execution Team Lead (SETL).
- Coordinate with DICE QA to ensure documents are synchronized and/or migrated between DICE QMS (Quality Management System) and the study-specific TMF, as needed
- Leads TMF consolidation efforts in preparation for TMF archival, including overseeing internal document processing activities for uploading to the CRO TMF.
- Develop and drive DICE processes in support inspection readiness needs; lead and facilitate the implementation of necessary changes.
Preferred Experience and Education:
- Associate’s/Bachelor’s degree or a combination of relevant education and applicable job experience may be considered
- Thorough knowledge and understanding of regulatory authorities, GCPs, ICH guidelines and regulatory requirements for TMFs
- Knowledge of ALCOA document standards
- Thorough knowledge of DIA Reference Model
- At least 5 years working in the pharmaceutical or biotechnology industry or equivalent, including minimum 3 years TMF experience
- Experience managing multiple projects, and able to identify and resolve issues
- In-depth experience in TMF systems such as Veeva Vault TMF, Trial Interactive etc.
- Previous TMF Oversight /QC responsibilities are critical
Preferred Additional Skills:
- Attention to detail and quality
- Strong organizational and time-management skills
- Excellent written and oral communication skills
- Team player; comfortable and effective in a collaborative research environment
Document Specialist: $119k – $142k
Sr. Document Specialist: $136k – $159k
The pay range for this position that we reasonably expect to pay. Individual compensation is based on various factors including, experience, education, skillset, and geographic location. This range is for the Bay Area, California location and may be adjusted to the labor market in other geographic areas.
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.