Clinical Operations Manager

1 semana atrás

Lisboa, Lisboa, Portugal MSD Tempo inteiro

Reporting into the Clinical Research Country Lead, the incumbent will be accountable for performance and compliance of assigned protocols in a country in compliance with International Council for Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.


Responsibilities include, but are not limited to:

  • Execution and oversight of clinical trial country submissions and approvals for assigned protocols, according to required timelines and country commitments and objectives particularly during study start-up.
  • Development of local language materials including local language Informed Consents and translations. Interaction with Ethics Committee and Regulatory Authority for assigned protocols.
  • Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
  • Ownership of country and site budgets and payments management; responsible for financial compliance. Development, negotiation, and completion of Clinical Trial Research Agreements (CTRA). Oversight and maintenance of all applicable financial systems.
  • Coordination and liaison with other internal Departments (Finance, Legal, Regulatory and Pharmacovigilance) and with external Vendors to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
  • Contribution to the development of local Standard Operating Procedures and act as process Subject Matter Expert (SME) for assigned topics.
  • Leading local initiatives or projects important to core business.
  • Contribution as buddy/mentor for new team members and to leading a team of CTCs, as applicable.

Competency Expectations:

  • Problem solving is essential to this position. Requires the ability to proactively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable.
Specific examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.

  • Strong communication, coordination, prioritization, networking and conflict management skills.
  • Ability to directly or indirectly influence investigators, vendors, external partners and key stakeholders (internal and external) to address and resolve issues and meet with agreed commitments and timelines, with mínimal support from the manager.
Travel: 10% time required

Training & Experience:

  • Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.
  • 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business.
  • Excellent verbal and written, negotiation and training/mentoring skills, in Portuguese and English
  • Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study startups, in particular the European Clinical Trial Regulation (EU CTR) requirements and timings. Expertise of core clinical systems and tools.
Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else.

For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.

Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world.

Here, you have that opportunity.

You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.

Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.


Search Firm Representatives Please Read Carefully

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:
R214853

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