Advanced Clinical is seeking an experienced Clinical Research Lead to join our Functional Service Provider team in Germany.Working exclusively with a global biopharmaceutical company, the Clinical Research Lead will be responsible for the country-level operational delivery of strategic clinical studies. You will support senior Clinical Operations leadership and work closely with global study teams, CRO partners, CRAs, investigators and internal stakeholders to ensure studies are delivered to the required quality, timelines and regulatory standards.This role requires strong oncology experience and a thorough understanding of the German clinical research environment.

Key responsibilities

• Oversee local CRO activities for strategic outsourced clinical studies, acting as the principal country contact.
• Support the delivery of key country-level recruitment targets, study milestones and sponsor deliverables.
• Collaborate with global clinical study teams and monitoring functions on studies conducted in Germany.
• Partner with Study Start-Up Specialists and CRAs to ensure submission documentation is complete, accurate and appropriate for local ethics committee requirements.
• Coordinate and support country-level feasibility activities for both in-house and outsourced studies.
• Conduct high-level feasibility assessments covering competing studies, current standards of care, available treatments and potential regulatory considerations.
• Build and maintain professional relationships with investigators, clinical sites and Key Opinion Leaders.
• Support the allocation, mentoring and development of local CRAs.
• Conduct co-monitoring and CRA assessment visits when required.
• Support local procedures, quality initiatives, compliance reviews and inspection-readiness activities.
• Act as a Site Relationship Partner for assigned studies, maintaining strong relationships throughout the clinical study lifecycle.
• Collaborate with Medical Affairs, Quality Assurance, Study Start-Up, Global Monitoring, Clinical Trial Management and Regulatory teams.
• Ensure all activities are conducted in accordance with company procedures, ICH-GCP and applicable German and international regulatory requirements.

Qualifications and experience

• Bachelor’s degree or equivalent qualification.
• At least five years’ clinical research experience as a CRA, Lead CRA or Clinical Project Manager.
• Strong oncology clinical trial experience is essential.
• Dermatology experience would be advantageous.
• Experience supporting or overseeing clinical trials at country level.
• Strong knowledge of clinical trial methodology, drug development, monitoring activities, ICH-GCP and German regulatory requirements.
• Ability to mentor and provide operational support to local CRAs.
• Strong communication, stakeholder-management and cross-functional collaboration skills.
• Ability to develop effective relationships with investigators, sites, vendors and internal stakeholders.
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Advanced Clinical is seeking an experienced Clinical Research Lead to join our Functional Service Provider team in Germany.Working exclusively with a global biopharmaceutical company, the Clinical Research Lead will be responsible for the country-level operational delivery of strategic clinical studies. You will support senior Clinical Operations leadership and work closely with global study teams, CRO partners, CRAs, investigators and internal stakeholders to ensure studies are delivered to the required quality, timelines and regulatory standards.This role requires strong oncology experience and a thorough understanding of the German clinical research environment.

Key responsibilities

• Oversee local CRO activities for strategic outsourced clinical studies, acting as the principal country contact.
• Support the delivery of key country-level recruitment targets, study milestones and sponsor deliverables.
• Collaborate with global clinical study teams and monitoring functions on studies conducted in Germany.
• Partner with Study Start-Up Specialists and CRAs to ensure submission documentation is complete, accurate and appropriate for local ethics committee requirements.
• Coordinate and support country-level feasibility activities for both in-house and outsourced studies.
• Conduct high-level feasibility assessments covering competing studies, current standards of care, available treatments and potential regulatory considerations.
• Build and maintain professional relationships with investigators, clinical sites and Key Opinion Leaders.
• Support the allocation, mentoring and development of local CRAs.
• Conduct co-monitoring and CRA assessment visits when required.
• Support local procedures, quality initiatives, compliance reviews and inspection-readiness activities.
• Act as a Site Relationship Partner for assigned studies, maintaining strong relationships throughout the clinical study lifecycle.
• Collaborate with Medical Affairs, Quality Assurance, Study Start-Up, Global Monitoring, Clinical Trial Management and Regulatory teams.
• Ensure all activities are conducted in accordance with company procedures, ICH-GCP and applicable German and international regulatory requirements.

Qualifications and experience

• Bachelor’s degree or equivalent qualification.
• At least five years’ clinical research experience as a CRA, Lead CRA or Clinical Project Manager.
• Strong oncology clinical trial experience is essential.
• Dermatology experience would be advantageous.
• Experience supporting or overseeing clinical trials at country level.
• Strong knowledge of clinical trial methodology, drug development, monitoring activities, ICH-GCP and German regulatory requirements.
• Ability to mentor and provide operational support to local CRAs.
• Strong communication, stakeholder-management and cross-functional collaboration skills.
• Ability to develop effective relationships with investigators, sites, vendors and internal stakeholders.