[Position]

Clinical Trial Manager (Location: Boston/working from home possible)

[Company Overview]

Voronoi Inc. (KOSDAQ:310210) is a public Korean biotechnology company dedicated to discovering and developing novel small molecule precision medicine for the treatment of cancer.

Leveraging its proprietary drug discovery platform, Voronoi's focus is on discovery and development of therapies that take aim at multiple classes of precision medicines in solid tumors, including direct targeting of oncogenic pathways and synthetic lethality.

Voronoi offices are located in Kendall square, Cambridge, MA and Incheon, Korea.

We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at Voronoi. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward.

[Key Competency requirement]

- Excellent interpersonal, organizational, and teamwork skills required to communicate effectively with external collaborators and internal project teams.

- Ability to multi-task in a fast-paced dynamic environment while demonstrating a calm and positive attitude and a superior work ethic

- Experience with managing external resources including CROs and consultants

- Willingness to go “the extra mile” to accomplish tasks and responsibilities

- Responsive and proactive, with the ability to work well under tight deadlines and to respond to rapidly changing demands and priorities from multiple business owners to ensure on time delivery

- Seek diverse viewpoints

- Communicate directly, openly and honestly

- Challenge the status quo to simplify work and improve results

- Meet challenges with enthusiasm

- Excellent verbal and written communication and presentation skills.

- Flexibility, with the willingness and ability to manage through strategic shifts.

- Strong learning orientation, curiosity, and passion for science and patients.

- Excellent computer skills (Microsoft Office Word, Excel, PowerPoint, Outlook) required

[Experience requirement]

- Thorough understanding of ICH-GCP guidelines and local regulatory guidelines or regulations as they apply to protocol/site management.

- Knowledge of general clinical research including Investigator site issues, important milestones and strategies to ensure timelines are met.

- Experience in oncology clinical trials (phase I/II); early development experience required, late-stage experience a plus.

- Experience in small molecule targeted therapeutics in oncology including breast cancer and lung cancer a plus

- Extensive experience in dynamic start up or small company/lean business environments required.

[Job description]

- In this new role, you will be responsible for the management of clinical trial activities on one or more of our lead programs.

- You will collaboratively manage a global and early phase clinical trial through the development of the novel drug with focus on the areas of trial planning, enrollment, site monitoring, data quality, and study reporting.

- You will bring early phase experience including IND submission, and having strong vendor management as well as project management skills.

- You will develop an understanding of the needs of the teams with a collaborative outlook and the ability to manage workloads to meet project timelines.

[Essential Duties and Responsibilities]

- You will manage clinical trials from start-up through close-out to ensure both internal and external deliverables are on time and on budget while facilitating collaboration across functional areas

- Work with the cross functional team to coordinate the relevant and timely exchange of information/materials to support clinical trial delivery and execution

- Contribute to clinical development strategy and execution of the clinical development plan

- Oversee the development of clinical trial project timelines and ensures communication and understanding of risks/challenges; establishes plans with minimal oversight and monitors metrics; ensures that timelines are accurate and comprehensive

- Participate in site identification, evaluation, contracting, initiation, monitoring, and close out visits

- Participate in the selection and contracting of third-party vendors if necessary

- Conduct ongoing data reviews; prepare and present summaries to internal and external stakeholders

- Proactively manage clinical trial outsourced partners (which may include central and specialty labs, imaging, cardiac safety, and IRT vendors) including identification of risk, to ensure trial deliverables and performance goals are met

- Day-to-day contact with CRO counterpart; daily review and identification of potential issues or problems with sites and communicates/escalates as necessary

- Communicate with clinical site staff, investigators, and CROs as appropriate to ensure optimal sponsor-site relationships

- Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems

- Monitor clinical data entry progress and follow up with CROs on incomplete data entry and/or outstanding

queries

- Proactively manage and track project scope and change orders, for clinical trial operations

- Support the management of site-related activities, development of tracking tools, and manage recruitment timelines

- Facilitate clinical trial agreements with legal

[Required Education and Experience]

- BS/BA or master's degree in a scientific discipline, or other relevant advanced degree in a health science field

- Minimum 3 years of experience in the pharmaceutical or biotechnology industry as related role

- Working knowledge of the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and other applicable regulatory guidelines required

- Familiar with electronic data capture systems

- Detail-oriented with ability to prioritize tasks and function independently as appropriate

- Manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines

- Strong organizational skills and an ability to interpret, discuss, and report trial/program level data effectively and identify trends

- Some travel will be required (10-20%)

[Requirement]

U.S Citizen or Green Card Holder

[Contact/Apply]

Voronoi HR : voronoi.hr@voronoi.io

Voronoi Career : https://voronoi.career.greetinghr.com/o/101607