Senior Study Startup Specialist

Systimmune•Princeton, NJ

2d•$90,000 - $115,000•Hybrid

About The Position

The Senior Study Startup Specialist is responsible for leading complex and/or global study start-up activities across the clinical portfolio in a fast-paced biotech environment. This role serves as a subject matter expert (SME) in site activation strategy, regulatory submissions, and start-up process execution, and provides mentorship and guidance to junior Study Start-Up Specialists. The Senior Specialist drives timely site activation and enrollment readiness in compliance with ICH-GCP, SOPs, and local regulatory requirements, while identifying and mitigating risks, optimizing activation timelines, and setting standards across the function. This position plays a critical role in enabling the success of SystImmune's oncology clinical development programs.

Requirements

Bachelor's degree in Life Sciences, Nursing, Business, or related field required; advanced degree preferred.
Minimum 5-8 years of progressive experience in clinical study start-up, site activation, or regulatory submissions within the biotech, pharmaceutical, or CRO industry.
Demonstrated experience leading start-up for complex and/or global clinical trials.
Oncology clinical trial experience required; experience with biologics, bi-specifics, ADCs, or cell therapy programs strongly preferred.
Deep working knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements for clinical trial initiation.
Proven experience mentoring and developing junior team members.
Advanced proficiency with CTMS, eTMF, and clinical trial platforms.
Strong contract and budget negotiation experience.
Exceptional organizational, project management, and risk-management skills.
Ability to thrive in a fast-paced, ambiguous startup environment and pivot quickly.
Strong written and verbal communication skills; able to communicate complex issues to senior stakeholders.
Demonstrated ability to drive process improvements and set standards across SSU function.

Nice To Haves

Advanced degree preferred.
Experience with biologics, bi-specifics, ADCs, or cell therapy programs strongly preferred.

Responsibilities

Lead and oversee study start-up activities for complex, multi-site, and/or global clinical trials, ensuring timely site activation and enrollment readiness.
Serve as the subject matter expert (SME) for study start-up across cross-functional teams, providing guidance to clinical operations, regulatory affairs, CRAs, and clinical sites.
Develop and execute site activation strategies that optimize timelines, reduce cycle times, and address risks in resource-constrained or ambiguous environments.
Own and escalate start-up risks to leadership; propose mitigation strategies and drive resolution across functions.
Prepare, review, and submit complex regulatory documents to IRBs, ethics committees, and regulatory authorities (IND, IRB/EC submissions, FDA forms, country-specific filings).
Lead contract and budget negotiations with clinical sites in partnership with legal, finance, and clinical operations stakeholders.
Set standards and drive continuous improvement for SSU processes, SOPs, templates, and tools; lead process improvement initiatives and contribute to scalable SSU infrastructure.
Provide CRO oversight for start-up deliverables, including quality reviews, KPI tracking, and issue escalation.
Track and report start-up milestones (site activation timelines, enrollment readiness, submission approvals) to study teams and senior leadership.
Ensure the eTMF and all study documentation are audit- and inspection-ready; support regulatory inspections and audits as needed.
Apply advanced understanding of oncology clinical development to inform SSU planning, site feasibility, and execution strategy.
Stay current on evolving global regulations (ICH-GCP, FDA, EMA, GDPR, local requirements) and adapt processes accordingly.
Communicate complex start-up issues clearly and concisely to senior stakeholders, including written status updates and risk summaries.
Drive continuous process improvement initiatives by identifying inefficiencies, recommending solutions, and implementing standardized workflows to improve cycle times, quality, and inspection readiness.
Monitor metrics and KPIs related to start‑up performance, leveraging trends and lessons learned to refine processes and inform risk mitigation plans on current and future studies.
Coach and mentor junior study startup specialists.