**Job Description**:
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation.
Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents.
The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities.
The role will collaborate at local level closely with Clinical Operatios Management, Clinical Research Management and Clinical Research Associate.
**Responsibilities** include,** but **are** not **limited** to**:
- ** Regulatory** & Site** Start**-Up** responsibilities**:
- Works with other country roles;
- In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions;
- Obtain, track and update study insurance certificates;
- Support preparation of submission package for IRB/ERC and support regulatory agencies submissions;
**Main requirements**:
- Bachelor's degree;
- Proficient English language skills;
- Good comprehension of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines;
- Hands on knowledge of Good Documentation Practices;
- Strong Microsoft Office Excel skills required;
- Excellent negotiation and communication skills;
- Effective time management, organizational and interpersonal skills, conflict management;
- High sense of accountability / urgency;
- Ability to set priorities and handle multiple tasks simultaneously in a changing environment;
- Works effectively in a matrix multicultural environment;
- Demonstrates commitment to Customer focus, both internally and externally.
We are a research-driven biopharmaceutical company.
Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world.
We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
**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.
**Invent.
**
**Impact.
**
**Inspire.
**
**We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
**
**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**:R201847