Position: Clinical Operations Manager

at  Meditrial Europe Ltd

Meditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs and market access. Our offices are located in Germany, Italy, Switzerland, UK, United States and our teams rely on digital tools to work collaboratively to achieve shared goals.
Since 2008, Meditrial delivers unparalleled outcomes for innovators. Our successful track record supporting the lifescience industry manufacturers in all phases of clinical development puts us in a prime position to seize the opportunity to emerge as a leader in digital technology with the promise that it will enhance and alleviate the clinical trial and participant burden. Through our work, the patient and innovator are empowered with data and insights across the lifecycle of product development and market penetration changing the paradigm of care towards understanding and value. We have the ability to transcend the current landscape with “smart” technology enabled data collection tools and insights.
Meditrial offers highest level expertise across multiple therapeutic areas. We are passionate about our mission to support the innovation and development of better therapies in compliance with solid ethical standards. Our commitment has resulted in excellent results for business growth by creating stability and opportunities for employees and collaborators.

POSITION: CLINICAL OPERATIONS MANAGER:

Industry: Lifescience Industry: Pharma, Medtech, Digital Health
Employment Type: Full-time
Job Functions: Clinical Affairs
Location: Meditrial GmbH, Kantstrasse 21, 10623, Berlin, Germany
Workplace: Office-based / availability to travel
Meditrial is looking for a highly motivated, experienced clinical operations leader with a proactive attitude and the ability to work independently and as part of a team, and to interact with multiple internal and external stakeholders. The role will work in our office in Berlin, and will be focused on the management of Phase-I/II multi-centric clinical programs. The role should be able to work in a fast-paced environment with strong attention to detail and requires strong technical and client management skills, the ability to work with cross-functional teams: Sales, R&D, Management, Regulatory Affairs, and Marketing.

Responsibilities

• Provide strategic input on clinical operations goals
• Contribute to the management of clinical operation activities for efficiency, quality, and progress
• Responsible for the successful management of clinical programs by day-to-day CRO management
• Responsible for monitoring study progress and metrics including – but not limited to- study start up at the sites, patients’ enrolment, data collection and clean-up
• Responsible for preparing study progress reports and updates for leadership meetings
• Liaison with clients, establishes quality guidelines to ensure CROs are meeting highest standards
• Ensures timely responses to clinical site staff queries
• Develop working relationships with clients, key investigators, and other key staff/vendors
• Work on clinical operation documents as needed
• Collaborate with the clinical team to identify study investigators and clinical sites

Skillset & Qualifications

• 8-12 years experience in clinical/scientific medical devices/pharmaceutical clinical trials and research.
• 5 years’ experience managing projects and working with clinical professionals and cross-functional product development teams
• Well versed in EU and FDA regulations and standards and GCP, ICH guidelines
• Familiar with the laws, regulations, standards, and guidance governing the conduct of clinical studies
• Excellent leadership, management, collaboration, and effective decision-making skills
• Education: Bachelor’s degree in Lifescience, Master in a health-related field is a plus
• Languages: fluent English and German language is considered a plus
• Previous experience in a pharmaceutical, CRO or medical device company required
• Sound knowledge of GCP/CFR/ICH guidelines, ISO9001 and ISO14155 ISO 13485

• Provide strategic input on clinical operations goals
• Contribute to the management of clinical operation activities for efficiency, quality, and progress
• Responsible for the successful management of clinical programs by day-to-day CRO management
• Responsible for monitoring study progress and metrics including – but not limited to- study start up at the sites, patients’ enrolment, data collection and clean-up
• Responsible for preparing study progress reports and updates for leadership meetings
• Liaison with clients, establishes quality guidelines to ensure CROs are meeting highest standards
• Ensures timely responses to clinical site staff queries
• Develop working relationships with clients, key investigators, and other key staff/vendors
• Work on clinical operation documents as needed
• Collaborate with the clinical team to identify study investigators and clinical site