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.

Essential Functions:

In this entry-level role, you will provide direct support to the Clinical Operations group. You will assist with the planning, implementation and oversight of multiple studies within a clinical development program. 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 administrative support, as directed. You must have a positive, proactive, creative mindset and be open to navigating ambiguity. 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.

Key Responsibilities:

• Contributes to Clinical Operations efforts, which may include Clinical Informatics & Analytics, Program Management and/or Vendor Management tasks

• Contributes to the set-up and/or close out of vendors, as requested
  

• Assists with invoice /budget reconciliation for clinical trial vendors
  

• May participate in the review of clinical data in the EDC, data listings, or reports
  

• Assists with the development of new tracking tools and processes
  

• Ensures that delegated tasks are executed under ICH/GxP and DiCE quality standards
  

• Expands basic knowledge of clinical trials operations and scientific principles and objectives of DiCE’s clinical trials under direction and guidance of senior staff
  

• Completes a variety of other clinical trial-related responsibilities as assigned and agreed upon with direct manager
  

Preferred Experience and Education:

·        Previous clinical experience a plus

·        Knowledge of Good Clinical Practices (FDA and ICH)/ understanding of 21 CFR Part 11, 50,54,56, & 312 and ICH E-6(R1 & R2) is a plus

·        Basic knowledge and understanding of clinical trial processes is expected

·        Strong attention to detail and excellent communication and organizational skills

·        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; welcomes feedback; supports other's efforts to succeed; contributes to a positive corporate culture

·        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

DISCLAIMER

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.