Clinical Trial Coordinator

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.

The **Clinical Trial Coordinator (CTC)** is responsible for supporting country submission to HA/EC under the oversight of the Senior Clinical Operation Managers (SrCOM) or Clinical Operation Managers (COM) and is responsible to manage clinical trial documents and administrative tasks (i.e.budget/sites’ payments)

The CTC ensures timely maintenance of tracking and reporting tools.

The role will collaborate at local level closely with COM, CRM (Clinical Research Manager) and CRA (Clinical Research Associate).

**Responsibilities include, but are not limited to**:
**Support Trial overall management (from start up to close out)**
- Support country trial submission to HA/EC (support the release of essential documents i.e. Informed Consent Forms, Submission letters, Synopsis): Track documents and generate applicable reports; Update clinical trial databases (CTMS) and trackers

**Document management**:

- Support preparation of study documents and their archive/reconciliation
- Support quality checks according to local plans
- Support the preparation of Investigator Trial File binders

**Regulatory & Site Start-Up responsibilities**:

- Collaborate with other country roles to: Support preparation of country trial submission package to HA/EC from phase I to III trials; Informed Consent Forms release in collaboration with COM; Clinical trial payments as applicable
- Meeting Planning: Organize meetings if needed (face to face/virtual)

**Experience Requirements**:

- Minimum 2 years in Clinical Research or relevant healthcare experience

**Educational Requirements**:

- B.A./B.S. (Life Science preferred)

**CORE Competency Expectations**:

- Proficient in English (verbal and written) and excellent communication skills- CH-GCP Knowledge

**Behavioral Competency Expectations**:

- Effective time management, organizational and interpersonal skills, conflict management
- Effective communication with external customers (e.g. sites and investigators)
- 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. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus, both internally and externally.
- Able to work independently
- Proactive attitude to solving problems / proposing solutions

**Who we are **
We are known as Merck & Co., Inc., Kenilworth, 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.

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.

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**Employee Status**:
Regular**Relocation**:
No relocation**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R164647