Clinical Trial Coordinator

Job Description

An amazing opportunity has arisen for a Senior Clinical Trial Coordinator. This role is responsible for comprehensive trialand site administration and involves preparing collating distributing and archivingclinical documents. The Clinical Trial Coordinator (CTC) supports clinical supply & non-clinical supply managementand ensures timely maintenance of tracking and reporting tools as applicable.

What you will do:

Bring energy knowledge innovation and leadership to carry out the following:

• 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 CTC 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 Institutional Review Board (IRB)/ Ethics Review Committee (ERC) and Health Authorities.
• The role collaborates at local level closely with Clinical Operations Manager (COM) Clinical Research Manager (CRM) and Clinical Research Associate (CRA). And the person collaborateswith finance/budgeting representatives to manage Clinical Trial Research Agreements (CTRAs) and payments.
• The person acts as process Subject Matter Expert (SME) making recommendations for continuous improvement providing training as appropriate/required and mentoring junior Clinical Trial Coordinators (CTC).
• Trial and site administration: Responsible of managing and supporting essential trial site documents including tracking updates safety clinical and non-clinical supplies prepare documents and correspondence eTMF reconciliation Investigator site file preparation.
• Budgeting Agreement and Payments.
• Organize meetings (create & track study memos/letters/protocols.
• Quality & Oversight.

What skills you will need:

In order to excel in this role you will more than likely have:

• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills.
• 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) and ability to adapt to new IT applications. Strong MS Excel skills required.
• ICH-GCP Knowledge appropriate to role.
• Excellent negotiation skills for CTCs in finance area.
• Highly 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.
• Able to work independently taking full ownership of delegated tasks.
• Proactive attitude to solving problems / proposing solutions.
• Positive mindset growth mindset.

Qualification & Experience:

• Minimum 3 - 5 years in Clinical Research or relevant healthcare experience.
• Completed job training (office management administration finance health care preferred) or Bachelors Degree.
• Based in Ireland.

As a company we are committed to Inventing for Life in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds most challenging healthcare needs.

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.

So if you are ready to:

Invent solutions to meet unmet healthcare needs Impact the future by driving one of the worlds leading healthcare companies and inspire your team to reach their full potential and push the boundaries of science and technology please apply today.

Search Firm Representatives Please Read Carefully:

Our company does not accept unsolicited assistance from search firms or recruitment agencies for this employment opportunity. Please no phone calls or emails. All resumes submitted by search firms to any of our employees via email the Internet or in any form 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 the candidate is hired by our Company as a result of the referral or through other means.

Required Skills:

Preferred Skills:

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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.

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