At DiCE Molecules, 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 will provide direct support to the Clinical Operations team with project support related to clinical studies. You must have a positive, proactive, creative mindset and be open to navigating ambiguity. The Senior Clinical Trial Associate (CTA) will support Clinical Trial Managers (CTMs) to ensure the successful delivery of clinical trial data. You will assist with the planning, implementation and oversight of multiple studies within a clinical development program. The Senior CTA will also work closely with other cross-functional representatives including Regulatory, Biometrics, Development Sciences, Project Management, Research and QA to ensure successful completion of all clinical activities and project deliverables within the required time frame. You will facilitate the creation of meeting agendas and minutes, track study activities and documents using a variety of tools and systems, assist with reviewing clinical data, and provide full support for the filing and oversight of the Trial Master File (TMF). The Senior CTA may also support oversight of the CRO and other third-party vendors on assigned studies. You will be responsible to assure adherence to GxP in conduct of DiCE clinical trials, the quality and integrity of generated data, and the rights and welfare of participants/patients.
This position is based in South San Francisco. No relocation assistance provided.
· Contributes to study management efforts under the direction and guidance of the CTM; assists with development of study plans and documents, including informed consent forms (ICFs), protocols, and amendments, project management plans, study reference manuals, etc.
· Primary Clinical Operations support role; facilitates the creation of meeting agendas and presentations /slides and takes precise minutes for study team meetings; maintains internal working files and study tracking information; develops study-specific tools for tracking and reporting for Clinical Operations team; provides timely study-level KPI updates to the Clinical Operations leadership team
· Contributes to the set-up, oversight and close out of vendors, as requested
· Assists with planning of Investigator Meetings; attends and leads presentations at Investigator Meetings, as requested
· Coordinates development, procurement and management of study-specific training materials and supplies, as required; provides study level information to stakeholders and vendors to enable accurate and efficient supply of clinical /non-clinical supplies to sites
· Tracks clinical /non-clinical supplies, lab samples, etc.; performs reconciliation on request
· Oversees all activities related to the Trial Master Files; creates, maintains, and closes out TMFs; leads TMF reconciliation and/or audits and related activities /follow-up
· Assists with project scoping, invoice reconciliation and change orders for clinical trial vendors
· Participates in the review of clinical data in the EDC, data listings, or report tables
· Participates in the review, approval, and tracking of clinical monitoring visit reports in conjunction with the Clinical Trial Manager and ensures that all outstanding follow up items are closed out in a timely manner; occasionally attends SIVs, IMVs, and COVs
· Maintains day-to-day contact with counterpart at CRO and/or trial site; daily review and identification of potential issues or problems with the sites and communicates/escalates to CTM or senior Clinical Operations staff
· Represents DiCE in interactions with clinical sites to resolve issues and/or obtain documentation, as needed.
· Ensures that delegated components of clinical trials are executed as expected and to ICH/GxP and DiCE quality standards
· Supports study goals by working closely and communicating effectively with internal and external cross-functional study team members
· Expands basic knowledge of clinical trials operations and scientific principles and objectives of DiCE’s clinical trials under some direction and guidance of senior staff but largely self-directed; works independently but knows when to involve / collaborate with others
· Builds best practices in clinical operations methodologies, systems and processes, and knowledge management with particular emphasis on quality, time standards and expectations
· Assists with the development of new tracking tools and processes
· Completes a variety of other clinical trial-related responsibilities as assigned and agreed upon with CTM and direct manager
· Fully understands the need for and importance of being inspection ready and diligently follows all DiCE SOPs; identifies and communicates if there are gaps
· Actively participates in Clinical Operations departmental meeting sand initiatives; proactively contributes ideas to enhance the efficiency and effectiveness of Clinical Operations
· Participate in and/or lead forums critical to Clinical Operations objectives
· Travel required: potential domestic and international travel, up to 20%
Preferred Experience and Education:
· Bachelor’s degree or equivalent training and experience
· Minimum of 5 years of experience in Clinical Operations(Sponsor or CRO setting)
· Minimum 2 years direct experience managing eTMF and clinical trial databases /systems
· Prior experience as a Study Coordinator or CRA is a plus
· Early Development experience required. Start-up experience a plus
· Experience in immunology therapeutic areas, specifically related to design /quality oversight of trials is a plus
· Strong knowledge of Good Clinical Practices (FDA and ICH), a solid understanding of 21 CFR Part 11, 50,54,56,& 312 with respect to clinical systems, including database, eCRF validation procedures, eCTD Quality Assurance, eTMF requirements and ICH E-6(R1 & R2)
· Current and working knowledge interpretation/implementation of government and other local state/government regulations/requirements governing the ability to work in a clinical setting, demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, as well as preparation of clinical documentation in support of regulatory submissions required
· Extensive knowledge and understanding of clinical trial processes as well as quality management and control tools is required
· Proven ability to manage multiple projects while maintaining quality is required
· Strong attention to detail and excellent communication and organizational skills
· Able to proactively identify logistical problems and propose solutions
· Uses time efficiently, completes tasks correctly and on time, follows instructions and responds to management direction
· Treats people with respect; has strong interpersonal skills, inspires the trust of others; works with integrity and ethics; upholds DiCE organizational values
· Is a true team player; gives and welcomes feedback; contributes to building a positive team spirit; supports other's efforts to succeed; contributes to a positive team spirit; shares expertise /mentors junior colleagues
· Ability to think strategically and objectively and with creativity and innovation
· Strong computer skills required including MS Office (Word, PowerPoint, MS Project), including a high-level proficiency/expertise in Excel
· Position is based in South San Francisco, with potential for flexible work arrangements
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.