Voronoi, Inc. Clinical Trial Manager

Location: Applicants who are eligible to work in Waltham, MA office Boston are preferred.

Reports to: Chief Medical Officer

Employment Type: Full-time

Experience Level: 2+ years

• Support the clinical operation team under the supervision of Sr. Clinical Operation Manager.
• Assist with the review, tracking and monitoring the day-to-day aspects of clinical trials and ensure clinical trial documents are collected, recorded, and filed.
• Ensure clinical trials are conducted in accordance with the protocol, standard operating procedures, ICH/GCP, and all applicable regulatory requirements.

• Maintain the Trial Master File.
• Will adhere to applicable SOPs, WIS, policies, local regulatory requirements, etc.
• Complies with relevant training requirements.
• Review and track progress of clinical trial, essential regulatory documentation from clinical sites before study start‑up and throughout study conduct, such as financial disclosures, debarment checks, current CVs, GCPs, relevant certification and licensing requirements. Collect and file all documents throughout the trials and post‑trials activities. Support TMF quality control and reconciliation.
• Collect and prepare documents required for study, such as start‑up/submission to the IEC/IRB, in support of the CPM/Sr. CRA where applicable.
• Prepare study files for investigational sites and coordinate the development of associated documents and review them for completeness and accuracy.
• Maintain trial, country and site level protocol information in trial management systems.
• Manage study data, budget and payments, investigational products, mailing and correspondence and other relevant tasks in support of the CPM and Sr. CRA.
• Ensure current versions of the required trial documents, trial‑related materials and supplies are provided to the investigational sites within required time frames.
• Accountability of IP: partner with the internal/external team for IP shipment and transfers. Ensure accountability records are accurate from receipt through final disposition.
• Coordinate archiving of study relevant documents/files.
• Ensure audit and inspection readiness.
• Assist with user acceptance testing of eTMF and databases.
• Assist in the development of case report forms and case report form completion guidelines (CCGs).
• Provide process improvement suggestions if applicable.
• Provide updates to study specific internal data repositories to ensure availability of trial documents to the study team.
• If requested, organize training for SIVs or small investigator meetings.
• Assist clinical operation team with gathering agenda topics, preparing agenda, scheduling meetings, liaise with meeting planners, and coordinate logistics for internal or external meetings.
• Attend, participate, prepare, and distribute meeting minutes and action items for both internal and external meetings.
• Support preparations and response to audits, internal review, documentation, etc.
• Review Site Visit Reports for accuracy, quality and consistency.
• Assist with managing study vendors.

• Education:
  
  BA/BS degree in Life Sciences, Nursing or related scientific field.
• Required Experience:
  
  2+ years of relevant clinical trial experience with associated skill sets in oncology trials.
• Previous experience in the pharmaceutical industry/biotech (plus).

• Proficient in English (spoken and written).
• Strong knowledge of MS office (Word, Excel, and PowerPoint) and Adobe Acrobat.
• Strong interpersonal skills.
• Excellent organizational skills and the ability to collaborate and handle multiple priorities within a fast‑paced environment.
• Perform activities in a timely and accurate manner.
• Strong attention to detail is a must.
• Able to work in a fast‑paced, evolving biotech environment with focus on quality.
• Able to work flexible hours considering the time zone differences across Asia and the U.S.

• Applicants who are eligible to work in Boston are preferred.
• While this is a remote position, two days in the office per week are mandatory.

Voronoi is proud to be an equal opportunity employer. We are committed to fostering a diverse and inclusive workplace where every individual is valued, respected, and empowered to contribute to our shared mission of advancing transformative oncology therapies. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristic protected by applicable law.