Position: Clinical Operations Manager

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Clinical Operations Manager role at Meditrial

Industry: Life Sciences – Pharma, Medtech, Digital Health

Employment Type:

Full-time

Job Functions:

Clinical Affairs

Location:

Meditrial USA Inc., 866 United Nations Plaza, NY 10017

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 New York, 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.

• 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

• 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 Life science, Master in a health‑related field is a plus.
• Languages:
  
  fluent English, second language is a plus.
• Previous experience in a pharmaceutical, CRO or medical device company required.
• Sound knowledge of GCP/CFR/ICH guidelines, ISO
  9001 and ISO
  14155 ISO 13485.

Seniority level:
Mid‑Senior level

Employment type:

Full‑time

Job function:
Management and Manufacturing