Senior Clinical Trial Coordinator (Safety Reporting)

MSD

2mo ago

Applications are closed

Job
Full-time
Mid & Senior Level
Research & Development
Healthcare

Requirements

Minimum 3 - 5 years in Clinical Research or relevant healthcare experience.
Bachelor’s Degree.
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.
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.
Demonstrates commitment to Customer focus, both internally and externally.
Able to work independently taking full ownership of delegated tasks.
Proactive attitude to solving problems / proposing solutions.
Positive mindset, growth mindset.

Responsibilities

Trial and site administration: tracking essential documents including safety reports, ensuring collation and distribution of study tools and documents, updating clinical trial databases and trackers.
Document management: preparing documents and correspondence, collating, distributing/shipping, and archiving clinical documents, assisting with eTMF reconciliation, executing eTMF Quality Control Plan.
Regulatory & Site Start-Up responsibilities: providing to and collecting from investigators forms/lists for site evaluation/validation, site start-up and submissions, supporting preparation of safety report submission package for IRB/ERC and supporting regulatory agencies submissions.
Quality & Oversight: contributing to CTC team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required, mentoring junior CTCs.

FAQs

What is the primary focus of the Senior Clinical Trial Coordinator (Safety Reporting) role?

The primary focus of the role is on ensuring comprehensive trial and site administration, specifically concentrating on safety reporting.

What qualifications are required for this position?

A minimum of 3-5 years in Clinical Research or relevant healthcare experience, a Bachelor's Degree, proficiency in local languages and business English, and an understanding of Global and Country/Regional Clinical Research Guidelines are required.

What specific skills are needed for success in this role?

Required skills include strong MS Excel abilities, good IT proficiency, knowledge of Good Documentation Practices, effective time management, excellent interpersonal skills, and a proactive attitude toward problem-solving.

Will the candidate need to travel for this position?

The job posting does not specify travel requirements, so it is unclear if travel is necessary.

Is there an opportunity for mentorship in this position?

Yes, the role involves mentoring junior Clinical Trial Coordinators as part of the responsibilities.

What is the work arrangement for this position?

The position supports flexible work arrangements in a hybrid format.

What is the deadline for applying to this job?

The application deadline is 11/20/2024, as the job posting will close at 11:59:59 PM on that date.

Are there any specific regulatory responsibilities outlined for this role?

Yes, responsibilities include providing to and collecting from investigators for site evaluation, site start-up submissions, and supporting safety report submissions to IRB/ERC and regulatory agencies.

What kind of work environment can a candidate expect in this role?

The role is set within a matrix multicultural environment, emphasizing establishing and maintaining culturally sensitive working relationships.

Does the company offer any form of sponsorship for candidates?

The job posting does not specify any VISA sponsorship details.

MSD

We aspire to be the premier research-intensive biopharmaceutical company.

Science & Healthcare

Industry

10,001+

Employees

1891

Founded Year

Mission & Purpose

MSD, also known as Merck & Co. Inc. in the United States and Canada, is a global pharmaceutical company that focuses on discovering, developing, and delivering innovative healthcare solutions. They research and develop a wide range of prescription medicines, vaccines, biologic therapies, and animal health products. MSD's ultimate mission is to improve and save lives by addressing unmet medical needs and advancing healthcare worldwide. Their purpose is to develop innovative medicines and therapies that tackle diseases and conditions affecting individuals across the globe, with a strong emphasis on scientific excellence, patient-centricity, and ethical business practices. MSD strives to make a meaningful impact on public health by providing access to safe, effective, and high-quality healthcare solutions, while also contributing to the broader advancement of medical knowledge and healthcare systems

Culture & Values

Patients first
We are all accountable for delivering high quality products and services. We aspire to improve the health and wellness of people and animals worldwide, and to expand access to our medicines and vaccines. All of our actions must be measured against our responsibility to those who use or need our products.
Respect for people
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, safety and teamwork of our employees. We work to create an environment of mutual respect, inclusion and accountability. We reward commitment and performance and are responsive to the needs of our employees and their families.
Ethics and integrity
We are committed to the highest standards of ethics and integrity. We are responsible to all of our stakeholders: employees, patients, customers, distributors and suppliers, shareholders, and the communities we serve worldwide. We do not take professional or ethical shortcuts.
Innovation and scientific excellence
We are dedicated to the highest standard of innovation and scientific excellence. Our research is guided by a commitment to improving health and quality of life. We strive to identify and meet the most critical needs of patients and customers through continuous innovation across all areas of our business.