Site Management Lead m​/w​/d

Site Management Lead

The Site Management Lead (SML) is a key member of the Clinical Study Team (CST), responsible for overseeing all site management and monitoring activities conducted by the Contract Research Organization (CRO) in a clinical study. SML ensures high-quality execution of site-related processes from site selection through to site closure, while maintaining compliance with regulatory standards and study protocols. SML collaborates closely with Clinical Trial Lead (CTL), CST, and the CRO to develop study‑specific operational plans, including the Clinical Monitoring Plan, and plays a critical role in identifying and mitigating study-level risks.

• Serve as the primary liaison between the CST and the CRO for all site management activities.
• Oversee CRO performance to ensure compliance with contractual obligations, timelines, and quality standards.
• Lead or contribute to the development of the Site Management Oversight Plan and other study‑specific operational plans in collaboration with the CST.
• Identify study-level risks and contribute to the development and implementation of risk management and mitigation strategies.
• Manage and monitor site identification, feasibility assessments, and site selection processes.
• Ensure timely and complete submissions to Ethics Committees (ECs) and Institutional Review Boards (IRBs) by the CRO.
• Support and review site budget negotiations and contract finalizations.
• Ensure site readiness for initiation, including training, documentation, and logistical preparedness.
• Oversee and support site initiation visits (SIVs) and ensure timely site activation.
• Monitor patient recruitment strategies and enrollment progress across clinical sites.
• Ensure protocol compliance and data integrity through oversight of site monitoring activities.
• Collaborate with CRO to address site-level challenges and elevate issues to CTL and CST as needed.
• Ensure adherence to ICH‑GCP, regulatory requirements, and internal SOPs throughout the study lifecycle.
• Participate in audits, inspections, and quality assurance activities related to site operations.

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• Minimum 5 years of clinical research experience, including 3+ years in site management, clinical operations, or CRO oversight.
• Solid knowledge of ICH‑GCP, ISO standards, regulatory requirements, and clinical study operations.
• Proven ability to manage complex timelines, multiple stakeholders, and competing priorities.
• Strong interpersonal, communication, and negotiation skills with cross‑functional collaboration experience.
• Experience in sponsor oversight of CROs and external vendors.
• Familiarity with risk‑based and centralized monitoring strategies.
• Experience contributing to study‑specific operational plans (e.g., Clinical Monitoring Plan, Risk Management Plan).
• Strong analytical and problem‑solving skills with a proactive, solution‑focused approach.

• Exciting work environment at an international, innovative medical technology company.
• Germany‑wide public transportation pass fully paid for by the employer.
• Additional benefits such as a fitness allowance (Wellpass), bicycle leasing (Job Rad), in‑house yoga classes, or height‑adjustable desks.
• Company pension plan with an above‑average employer contribution.
• 30+ days of vacation and a workation option.
• Access to corporate benefits for employee discounts.