Study Start-up Lead

Description

JOB SUMMARY

The Study Start-up Lead (SSUL) reports to the Global Feasibility, Regulatory and Start-up Head and is responsible for leading and overseeing the full lifecycle of regulatory submissions for clinical trials conducted globally or regionally till last participant site is activated, ensuring startup deliverables and timelines achieved. This role provides strategic submission planning, cross-functional coordination, and subject matter expertise (SME) while ensuring timely, high-quality control, and compliant submissions across the NA and ROW. The SSUL is a senior technical leadership role, who plays a pivotal role in mentoring junior team members without direct line management responsibilities. The SSUL will work in accordance with company policies, SOPs, regulatory requirements in addition to financial and contractual obligations. 

RESPONSIBILITIES

• Regulatory submission and cross-functional Leadership
• Ensure all startup activities for projects are performed on time, within the scope and budget and in compliance with ICH/GCP guidelines, SOPs and protocol requirements
• Together with the study, Project Manager manages the strategic aspects of projects startup and mitigating any risk setting up the proper action plan.
• Provide oversight and coordinate SSU Specialists, assigned to their programs being the initial point of contact and supporting them with startup activities and investigative sites' liaison. Ensure all assigned SSU Specialists are adequately trained on project specific systems and procedures
• Serve as SME for EU CTR and CTIS processes, interpreting regulatory expectations
• Lead planning and execution of Initial CTAs, Part I & II submissions, Substantial Modifications (SMs), and all CTIS lifecycle activities for Europe and other countries and regions as well. 
• Oversee preparation and submission of Requests for Information (RFIs), ensuring high-quality and timely responses.
• Provide subject matter expertise for end-of-study activities, including End-of-Trial (EoT) notifications, Summary of Results, Lay Summary, CSR and CSRr submissions.
• Conduct quality oversight and ensure alignment with EU CTR, EMA guidance, and internal standards operating procedures
• Develop and maintain Startup plan and timelines for their projects and track progress ensuring project deliverables and milestones are reached.
• Ensure adequate resource allocation of Start Up specialists on the project, in collaboration with the respective line managers. 
• Responsible for coordinating EC/IRB and regulatory submissions or any other notification requested by the scope of the protocol.
• Ensure and oversight the proper adaptation of Subject Information and lnformed Consent documents according to local law and requirements.
• Ensure all Start Up documentation is submitted properly and on time to the Trial master File.
• Execute the Greenlight forms, ensuring all documents are in place and approved. 
• Measure and evaluate project startup deliverables and metrics.
• Update the Project Manager and customer with status of start-up progress and ensure a proper escalation of any issue detected.
• Support the Line management ensuring the maintenance of site, country and regional Start Up requirements and timelines database on the central repository (EC/IRB submission, Regulatory package, Clinical Trial Agreements specification) and compliance with those requirements.
• Support Business development activities participating in capability presentations/bid defenses and being part of the proposals strategic discussion.
• Provide performance feedback of the team members to the corresponding Line Manager.
• Ensure submissions adhere to EU CTR 536/2014, ICH-GCP, EMA guidance, and any other national requirements.
• Support audits and inspections related to submission activities.
• Contribute to the development and maintenance of SOPs, work instructions, and templates.

TRAVELING

Per study requirements (global travel may be required).

Requirements

• Bachelor’s or master’s degree in Life Sciences or related field.
• 3+ years’ experience working in global regulatory environment with EU CTR submissions and advanced CTIS expertise being a must. CTIS system expertise is required 
• Strong understanding of EU CTR timelines, dossier content, and results of reporting.
• Proven ability to lead complex submission programs.
• Excellent communication, prioritization, and problem-solving skills.
• Experience in pharma, biotech, or CRO.
• Knowledge of ICH guidelines, Good Clinical Practice regulations, regulatory intelligence, and EU regulatory strategy. 
• Strategic thinking with cross-functional leadership experience
• Problem-solving and analytical skills
• High attention to detail
• Excellent communication and presentation skills in bid defense or customer meeting