Clinical Operations Manager

hace 4 semanas


Ciudad de México, Ciudad de México MSD A tiempo completo

Job Description

This position is responsible for ensuring performance and compliance for assigned protocols in a specific country, adhering to ICH/GCP and country regulations, company policies, quality standards, and adverse event reporting requirements both internally and externally. Under the guidance of the Head COMs, the individual will oversee the execution of clinical trial country submissions, approvals, and readiness of sites. Key responsibilities include, but are not limited to:

  • Executing and overseeing clinical trial country submissions and approvals for assigned protocols.
  • Developing local language materials, such as Informed Consents and translations, and collaborating with IRB/IEC and Regulatory Authority.
  • Managing country deliverables, timelines, and results to fulfill commitments and ensure quality and compliance.
  • Contributing to the development of local SOPs and overseeing CTCs where applicable.
  • Coordinating with internal teams and external partners to obtain necessary country deliverables and aligning timelines.
  • Providing support and oversight to local vendors and overseeing various local processes.
  • Owning local regulatory and financial compliance to support successful trial outcomes.
  • Directly and indirectly influencing stakeholders and maintaining budget targets and payment timelines.
  • Collaborating internally and externally to drive initiatives and projects that enhance business value.
  • Sharing expertise and best practices with the team, acting as a Subject Matter Expert and providing mentorship.

Secondary Language(s) Job Description:

Core competencies:

  • Expertise in core clinical systems, tools, and metrics.
  • Strong verbal and written influencing, training, and mentoring skills in local language and English.
  • Effective coordination, organizational, and submission/approval process knowledge.
  • Ability to proactively address issues, lead a team, and make independent decisions.
  • Thorough understanding of the local regulatory environment and development of risk management plans.

Behavioural Competency Expectations:

  • Efficient problem-solving skills and time management.
  • Accountability, urgency, and strong communication/leadership skills.
  • Focus on multiple deliverables simultaneously, even in a remote setting.
  • Positive and growth mindset with the ability to influence site staff directly.

Experience Requirements:

Required: 5 years of experience in clinical research or related field.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Materials:

No

Job Posting End Date:

06/06/2024

*Note: Job postings are effective until 11:59:59PM on the day BEFORE the listed end date. Please ensure timely application submission.

Requisition ID: R292868


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