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Deutschland
Hybrid
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Project Manager based in Germany.
In this role, you will support the planning, coordination, and delivery of clinical research studies within a science-driven and collaborative environment. You will work closely with sponsors, cross-functional teams, vendors, and clinical sites to help ensure studies are delivered on time, within budget, and to the required quality standards. You will coordinate site activation, patient recruitment, study documentation, and project milestones while helping manage risks and resolve operational challenges. Working alongside experienced project management leaders, you will develop your expertise in clinical trial delivery, stakeholder management, and structured project execution. This opportunity is ideal for a clinical research professional ready to take the next step in project management while contributing to meaningful scientific work. You will also have opportunities to strengthen your leadership, problem-solving, and process improvement skills as you grow in the role.
Support the initiation, planning, execution, monitoring, control, and closure of assigned clinical research projects, ensuring adherence to approved budgets, scope, timelines, standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
Serve, when assigned, as a primary point of contact for sponsors, vendors, internal teams, and other project stakeholders, helping manage expectations and maintain effective communication.
Coordinate tasks, resources, and deadlines across departments to support timely study delivery and effective prioritization of site activation activities.
Work with project coordinators, site start-up teams, regulatory and clinical resources, and vendor management to align site activation activities, supplies, and services with project timelines.
Monitor project milestones and site activation progress, escalate risks or delays to senior project management colleagues, and contribute to corrective and preventive actions.
Support resource planning, project status reporting, study tracker reconciliation, change control, risk management, and the maintenance of project quality standards.
Review and contribute to project plans, operational processes, study manuals, and other documentation required for effective project execution.
Help ensure that study documents and deliverables—including protocols, informed consent forms, electronic case report forms, clinical study reports, and related materials—meet applicable country-specific and study requirements.
Coordinate site feasibility and selection activities, qualification visits, patient recruitment tracking, site follow-up, and investigator meeting planning.
Support central ethics committee and regulatory submissions in collaboration with regulatory affairs teams, where applicable.
Ensure essential site documentation is collected and kept up to date, and assist with Trial Master File (TMF) quality reviews and audit or inspection readiness.
Support clinical monitoring activities, including training, monitoring visit documentation, follow-up letters, site issue escalation, and compliance with the monitoring plan.
Maintain project-specific training matrices and verify that team members complete required training before performing study-related tasks.
Coordinate with clinical sites to help ensure the availability of investigational products, study supplies, laboratory kits, equipment, and other materials needed to conduct the study.
Collaborate with data management teams to support protocol-aligned case report forms, query resolution, data review, and database lock timelines.
Contribute to departmental training, technical knowledge sharing, and process improvement initiatives under the guidance of senior project management staff.
Bachelor's degree in a relevant field related to clinical research or a comparable discipline.
At least three years of experience in a similar role, including clinical study management activities within the pharmaceutical, biotechnology, or Contract Research Organization (CRO) industry.
At least two years of experience coordinating clinical trial management activities.
Strong knowledge of GCP and International Council for Harmonisation (ICH) standards, as well as relevant U.S. Food and Drug Administration (FDA) and Canadian regulatory requirements.
Proficiency in Microsoft Office applications and the ability to prepare accurate project documentation and reports.
Excellent written and spoken English; French language skills are an advantage.
Strong communication and interpersonal skills, with the ability to build effective working relationships with sponsors, colleagues, vendors, and clinical site teams.
Good organizational and problem-solving abilities, including the capacity to manage competing priorities and deliver against demanding timelines.
Experience managing small to medium-sized projects using a structured and disciplined project management approach.
Understanding of core project management principles and the ability to develop and deliver resource-based project plans.
Strong teamwork and people management skills, including experience coordinating teams in a matrix environment.
A proactive, detail-oriented approach to quality, compliance, stakeholder coordination, and continuous learning.
Legal authorization to work in the eligible hiring region is required; the original posting specifies applicants who can legally work in the EU. Switzerland-specific eligibility should be confirmed before applying.
Permanent, full-time position.
Flexible working schedule to support work-life balance.
Vacation allowance.
Home-based working arrangement, subject to role and location eligibility.
Ongoing learning, training, and professional development opportunities.
A stimulating, science-driven environment with collaborative colleagues.
Opportunities to develop clinical project management expertise and progress professionally.
Work that contributes to clinical research and the development of meaningful medical advances.