Description

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 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.
Communicate regularly with project teams, clinical research associates (CRAs), regulatory affairs, and clinical sites to ensure smooth site activation.
Contribute to continuous improvement initiatives related to start-up processes and tools.
Ensure compliance with ICH-GCP guidelines, company SOPs, and local regulations at all times.
Stay updated on evolving regulations (GCP, GDPR, etc.) and adapt processes accordingly.

Qualifications

Bachelor’s degree in Life Sciences, Business, or related field (advanced degree a plus).
2+ years in clinical study startup, site activation, or regulatory submissions (startup experience preferred).
Familiarity with clinical trial platforms.
Exceptional organizational and project management skills.
Ability to thrive in ambiguity and pivot quickly.
Strong negotiation and communication skills (written and verbal).
Experience in oncology study.

Compensation and Benefits:
The expected base salary range for this position is $70,000 - $95,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.

SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.

We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

Study Startup Specialist

Description

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