Clinical Trial Coordinator (m/f/d)

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 Clinical Trial Coordinator (m/f/d) supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.

The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities.

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.

The main responsibilities:

• Prepare documents and correspondence

• Collate, distribute/ship, and archive clinical documents, e.g. eTMF

• Assist with eTMF reconciliation

• Execute eTMF Quality Control Plan

• Update manuals/documents (e.g., patient diaries, instructions)

• Prepare Investigator trial file binders

• Collaborate with other country roles

• Provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions in a timely manner

Your Qualifications:

• Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree

• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

• Hands on knowledge of Good Documentation Practices

• Good IT skills (use of MS office, use of some clinical IT applications on computer) - strong MS Excel skills required.

• ICH-GCP Knowledge appropriate to role

• Excellent negotiation skills for CTCs in finance area

• 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. Ability to establish and maintain culturally sensitive working relationships.

• Able to work independently

• Excellent communication skills

• Proactive attitude to solving problems / proposing solutions

• Fluent in German and business proficient in English (verbal and written)

Our Benefits:

• Trustbased working hours (37.5 hours/week) and an attractive company pension scheme

• Competitive salary package: 13 monthly salaries + annual holiday pay + target bonus achievement

• 30 days holiday entitlement

• Basic equipment for the home office

• Internal further training and promotion opportunities

• International cooperation

• On-the-job training

• Contribution of own ideas to the process design

• Corporate benefits

• Company health management system

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.

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.

People with severe disabilities and their equivalents will be given preference if they are equally qualified.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R227867