Position: Clinical Operations Manager

Meditrial; Berlin; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

A leading company in the Lifescience sector is seeking a Clinical Operations Senior Manager in Berlin. The role involves managing Phase-II-IV clinical programs and requires at least 8 years of relevant experience. Candidates should have a strong regulatory background and excellent leadership and project management skills.

Qualifikationen

• Minimum 8 years experience in clinical/scientific medical devices/pharmaceutical clinical trials.
• 5 years’ experience managing projects with clinical professionals.
• Familiar with EU and FDA regulations and standards.

Aufgaben

• Provide strategic input on clinical operations goals.
• Responsible for successful management of clinical programs.
• Ensures timely responses to clinical site staff queries.

Kenntnisse

Leadership

Project Management

Regulatory Knowledge

Clinical Operations Management

Collaboration

Decision-Making

Ausbildung

Bachelor’s degree in Lifescience

Master in a health-related field

Jobbeschreibung

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 senior manager 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-II-IV 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

• minimum 8 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