Study Start Up Specialist

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

ProPharma is seeking an experienced Senior Study Start-Up (SSU) Specialist to join our team. In this role, you will lead and oversee SSU activities across the UK and EU, ensuring clinical trials are initiated efficiently, compliantly, and to the highest quality standards. You will work closely with cross-functional teams and clinical research stakeholders to deliver on critical timelines that bring life-changing therapies to patients.

Key Responsibilities

• Manage and deliver all study start-up activities from initiation through study close-out, including site feasibility, site identification, regulatory submissions, site activation, and ongoing maintenance.
• Lead site identification and feasibility assessments in assigned regions.
• Prepare and submit regulatory packages to Institutional Review Boards (IRB)/Ethics Committees (EC), including amendments and periodic updates.
• Support the development and adaptation of site- and country-specific informed consent forms (ICF).
• Execute start-up activities in alignment with study requirements, standards, and project timelines.
• Track, maintain, and analyze start-up metrics, ensuring efficiency and identifying opportunities for process improvements.
• Partner with study teams to provide expertise on regulatory and ethics requirements, and proactively drive site activations and submissions.
• Support study budget development and contract negotiations in collaboration with internal teams and legal counsel.
• Contribute to process improvements and the development of tools that increase project efficiency.

Skills & Competencies

• Strong communication, leadership, and interpersonal skills with the ability to collaborate effectively across internal and external stakeholders.
• Excellent organizational and time-management abilities with the capacity to prioritize multiple tasks.
• Proactive problem-solver with a continuous improvement mindset.
• Proficiency in clinical trial systems (eTMF, CTMS, EDC, DCT) and project management applications (e.g., Microsoft Office, SharePoint).
• Thorough knowledge of ICH-GCP guidelines and regulatory requirements.

Qualifications & Experience

• Bachelor's degree in a scientific or healthcare discipline preferred. Candidates with equivalent experience will also be considered.
• Minimum 5 years' experience in study start-up within clinical research, preferably with multinational studies.
• Demonstrated success in managing deliverables within start-up timelines.
• Experience supporting budget and contract negotiations is advantageous.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***