Freelance Regional Clinical Trial Manager

Join us in redefining what it means to work for a CRO. When you work at Rho, it’s more than just a job—you become part of the Rho Factor. We’re a proud bunch of science nerds who love tackling big challenges together. We’re not your typical CRO, and we’re not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do. We are currently hiring a Freelance Regional Clinical Trial Manager to join our amazing team! In this role, you will oversee clinical trial operations and site management across multiple locations, ensuring compliance with regulatory guidelines, and working closely with Principal Investigators and clinical staff. You will be responsible for the successful execution of clinical trials, maintaining timelines and budgets while ensuring the highest standards of quality. This is a freelance opportunity and we require around 156 hours per month. This contract will run until the end of 2026 and will then be renewed each calendar year, based on individual performance and business need. At Rho, our Regional Clinical Trial Managers are pivotal to our success, leading studies that can change lives and improve health outcomes for people around the world. What You Will Be Doing: Ensure appropriate and individual planning of study start up in order to achieve fast initiation of study sites Request assignment of CRO and (together with Purchasing and Vendor Management) support CRO contracting process Management of on-site logistics, e.g. IVRS and IWRS (IXRS), Investigational Medicinal Product (IMP) supply together with Clinical Trial Supply Unit (CTSU), equipment, lab in cooperation with the CRO Develop study specific Investigator Budget Tool. Support contract management with trial-specific information and monitor progress of contracting Plan and communicate study budget, timelines, capacities and obtain management approval as required Obtain approval for any legal changes in Informed Consent Form (ICF) Ensure preparation of Clinical Trial Master File (CTMF) and a sample Investigator Site File (ISF) in cooperation with interfaces Ensure timely initial submission to Ethics Committees (ECs) and Competent Authorities (CAs) in collaboration with vendor Regulatory and Start-up Team, monitor approval progress and maintain data in applicable databases Actively participate in Investigator Meetings, if required Supervise on site monitoring activities (including but not limited to timely turnover of on-site monitoring reports) Monitoring of budget, anticipation of budget implications of changes in the study and communication of budget changes Ensure appropriate submission to ECs and CAs of relevant documentation on ongoing basis (e.g. CTP amendments, Investigator’s Brochure updates, etc.) Manage local/regional patient recruitment and timelines and take appropriate measures to match OPU/regional recruitment commitments, patient retention and milestones Perform Co-Monitoring Visits to confirm data quality; CTP, GCP and SOP compliance and to support patient recruitment and retention Ensure availability of trial supply (e.g. IMP together with CTSU, equipment, laboratory material) throughout the trial Keep timelines for data clarification and data cleaning for data base lock Supervise and manage close out activities (collection of essential documents, IMP and equipment; destruction of IMP; completeness of e-CTMF; archiving of trial documents, etc.) Ensure end of trial notification and clinical trial reports are provided within respective timelines Manage Clinical Trial Coordinators (CTC), CRAs, and Business Partners allocated to the trial Manage regional clinical study progress and report progress as well as trial issues to Therapeutic Area Lead, at Clinical Project Review Meetings and to the CTLs at Country Oversight Meetings Provide information for Clinical Trial Management System in a timely manner Organize and conduct investigator meetings in the region, if needed Prepare for and participate in audits and inspections on request Evaluate CRA performance Ensure collection of financial disclosure questionnaires according to SOP in needed quality Degree in a related field (life sciences, nursing, etc.) with at least 5 years of experience in clinical trial management, preferably in a CRO or pharmaceutical environment. Proven experience managing regional or multi-site clinical trials successfully. Strong communicator with excellent written and verbal skills in English; knowledge of additional languages is an advantage. Detail-oriented with a commitment to quality and ethical conduct in clinical trials. High-Character: Collaborate with honesty and integrity; shown ability to build trust and work well within a team environment. Effective problem-solving and critical thinking skills, with the ability to adapt quickly to changing environments. Willingness to travel and have a valid driver’s license. Please submit your CV in English. We’re excited to hear from you and to discuss how you can be a part of the Rho Factor! We offer: A supportive and inclusive work environment with opportunities for personal and professional growth Competitive compensation based on experience Flexibility and autonomy in how you manage your work Engagement in impactful clinical trials that make a difference