Senior Study Start-Up Specialist in New York at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Study Start-Up Specialist based in the United States.

This role is responsible for driving high-quality clinical study start-up activities from site selection through activation.
You will coordinate submissions, essential documentation, and start-up deliverables while ensuring milestones are achieved efficiently.
The position combines operational ownership, regulatory awareness, document management, and close collaboration with clinical research stakeholders.
You will help accelerate site activation timelines by leveraging established site relationships and identifying opportunities to reduce cycle times.
The role also contributes to improving local workflows, systems, and study start-up infrastructure across North America.
You will work in a collaborative clinical operations environment where attention to detail, clear communication, and proactive problem-solving are highly valued.
This is an opportunity to make a direct impact on the timely initiation of clinical studies while supporting compliant and consistent execution.

• Manage study start-up activities and initial and ongoing submissions within established timelines, maintaining high standards of quality and compliance.
• Apply knowledge of ICH/GCP requirements, relevant country regulations and guidelines, and applicable SOPs throughout study start-up activities.
• Contribute to feasibility discussions and provide input related to site selection and start-up considerations.
• Drive and coordinate activities from site selection through activation, including providing accurate timeline input for site activation milestones.
• Lead the kick-off and completion of study start-up tasks, proactively monitoring progress and addressing potential delays.
• Leverage existing site partnership information and relationships to streamline start-up activities and reduce cycle times where possible.
• Coordinate informed consent form and submission activities, including document preparation, negotiation, and follow-up with relevant stakeholders.
• Prepare and submit required documentation to central IRBs to support timely review and approval.
• Ensure essential study and site documents are collected, reviewed, and maintained to appropriate quality standards.
• Complete accurate and timely study start-up data entry within the Clinical Trial Management System (CTMS).
• Ensure timely and high-quality filing of essential documentation within the electronic Trial Master File (eTMF).
• Support the development and implementation of local workflows designed to improve the efficiency and consistency of start-up deliverables.
• Contribute to the ongoing enhancement of study start-up infrastructure and processes across North America.
• Identify opportunities for operational improvement and help implement solutions that enhance efficiency, quality, and consistency.
• Collaborate effectively with clinical operations teams, sites, and other stakeholders to achieve study and functional objectives.
• Perform additional responsibilities as needed to support project, functional, departmental, or organizational goals.

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred.
• At least 3 years of progressive experience in clinical research and clinical operations.
• Experience within biotechnology, pharmaceutical, CRO, or clinical site environments is preferred.
• Practical knowledge of clinical study start-up processes, including site selection, activation, submissions, essential document collection, and study documentation.
• Working knowledge of ICH/GCP requirements, relevant regulations and guidelines, and clinical research SOPs.
• Experience with submission and document management processes, including central IRB submissions and informed consent documentation.
• Familiarity with CTMS and eTMF systems, with strong attention to data accuracy and document quality.
• Strong organizational and time-management skills, with the ability to manage multiple start-up activities and deadlines simultaneously.
• Excellent communication and collaboration skills, particularly when working with clinical sites and cross-functional stakeholders.
• Demonstrated initiative and a proactive approach to identifying risks, resolving issues, and improving processes.
• Strong analytical and problem-solving abilities with a results-oriented mindset.
• Ability to adapt to changing priorities and work effectively in a fast-paced clinical research environment.
• Commitment to teamwork, inclusivity, continuous learning, and clear communication.

• Annual base salary: $83,800–$113,800, with actual compensation determined by factors including job-related skills, experience, certifications, education, training, and work location.
• Eligibility for an annual bonus plan for non-commercial roles.
• Opportunity for discretionary equity awards and voluntary participation in an Employee Stock Purchase Plan.
• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan.
• FSA/HSA options.
• Life insurance coverage.
• Paid time off.
• Wellness benefits.
• Remote work opportunity within the United States.
• Opportunity to contribute to the successful launch of clinical studies and help improve study start-up processes across North America.
• Collaborative environment with opportunities to work alongside clinical operations professionals and diverse research stakeholders.