Study Startup Specialist

• SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ.
• It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs).
• SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications.
• Alongside ongoing clinical trials.
• SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development.
• We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
• The Startup Study Specialist is responsible for the successful initiation of clinical trials by coordinating and executing all study start-up activities across assigned projects within a fast-paced startup environment.
• This includes managing essential document collection, site activation, regulatory submissions, and ensuring compliance with ICH-GCP, SOPs, and local regulatory requirements.

The SSUA ensures that clinical sites are ready to initiate and enroll patients on time, contributing to the overall success of the clinical development program.

This requires hybrid work (3 days onsite) at our Princeton, NJ location.

Responsibilities

• Coordinate and oversee all aspects of study start-up activities for assigned clinical trials. Prepare and submit regulatory documents (e.g., IRB/EC applications, FDA forms) to ensure timely approvals.
• Track and report startup milestones (e.g., site activation timelines, enrollment targets).
• Support the development of SOPs and templates for scalable study execution.
• Propose solutions to reduce site activation timelines in resource-constrained environments.
• Prepare, review, and submit essential regulatory documents to ethics committees (ECs), institutional review boards (IRBs), and regulatory authorities.
• Track submissions and approvals to ensure study timelines are met.
• Support contract and budget negotiations by liaising with key stakeholders.
• Maintain accurate tracking systems and study documentation and document management systems (eTMF) and ensure audit readiness.