Sr. Spclst, Clin. Operations

3 semanas atrás

Lisboa, Lisboa, Portugal MSD Tempo inteiro

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy.

Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Our company is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company.

Today, we're doubling down on this goal.

Our research division is a true scientific research facility of tomorrow, and will take our company's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.


Key Responsibilities:

The role is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.


  • Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents
  • Participates & provides inputs on site selection and validation activities
  • Performs remote and onsite monitoring & oversight activities using various tools to ensure:
Data generated at site are complete, accurate and unbiased
Subjects' right, safety and well-being are protected

  • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive and accurate visit & nonvisit contact reports appropriately in a timely manner
  • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
  • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required
Supports and/or leads audit/inspection activities as needed

Knowledge Required
Master in Science (or comparable). Advanced degree (MD, PhD) possible but not required

  • Min. 2 years of direct site monitoring experience in a bio/pharma/CRO
  • Strong communication, educational/pedagogic, diplomatic and empathic skills
  • Strong organizational skills with demonstrated success required
  • Native Portuguese and fluent English
  • Problem solving and conflict resolution
  • Negotiation skills with both internal and external groups
  • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
  • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
  • Hands on knowledge of Good Documentation Practices
  • Proven Skills in Site Management including management of site performance and patient recruitment
  • Demonstrated high level of monitoring skill with independent professional judgment
  • Ability to understand and analyze data/metrics and act appropriately
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:

2

Requisition ID:
R215101

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