Senior Clinical Trial Assistant

Pivotal; Madrid; Sur place; EUR 30 000 - 45 000; Plein temps

Avantages offerts par ce poste

Career growth resources

Flexible work schedules

Training to enhance therapeutic knowledge

Résumé du poste

A leading contract research organization is seeking a Senior Clinical Trial Assistant in Madrid to manage project communications and e-TMF, support study logistics, and mentor junior staff. Ideal candidates will have at least 5 years of administrative experience in a CRO or Pharmaceutical setting, strong GCPs knowledge, and excellent communication skills. This role offers career growth opportunities in a vibrant work environment with a strong commitment to diversity and inclusion.

Qualifications

• Experience in administrative area at a CRO or Pharmaceutical Company for a minimum of 5 years is desirable.
• Ability to work under pressure is crucial.
• Empathy and ability to establish good relationships with others.

Responsabilités

• Act as a central contact for the team for assigned project communications.
• Perform document editing and manage e-TMF.
• Control and tracking of biological patient samples from sites to central labs.

Connaissances

GCPs/ICH knowledge

Organizational skills

Intermediate English

Team player

Strong communication skills

Formation

High School certificate

Outils

PC applications

Description du poste

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Senior Clinical Trial Assistant who shares our vision of providing clinical research excellence.

Joining Pivotal as a Senior Clinical Trial Assistant means that you will enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion into working in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal:

• We are passionate and fully committed to medical science while using technology, to make a positive impact.
• We provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life.
• We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives, being able to create a place where everyone feels like they belong.

Your responsibilities will include:

SCTA Clinical Operations

• Act as a central contact for the team for assigned project communications, correspondence and associated documentation.
• Start-up activities: feasibilities under direction of Project Director (PD), Project Manager (PM) and or Lead CRA, obtain site contact information, essential documents, etc.
• Initiate, maintain and reconcile e-TMF, In-House TMF & ISF
• Organize study information on shared file drives.
• Organize and maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out.
• Perform document editing, adaptation, correction and format as needed.
• Control and tracking of biological patient samples from sites to central labs.
• Act as liaison for third party vendors and management of vendor invoices under PD, PM and or Lead CRA supervision and provide detailed Request for Proposals (RFPs) tailored to specialized vendors.
• Under the direction of PD, PM and or Lead CRA organize and coordinate the logistics of internal and external meetings such as CRA/ Investigator Meetings, etc.
• Support with travel management (BTU) and reception tasks if required.
• Perform other related duties relevant to the work described herein.

eTMF Specialist

• Processes study documents which may include but are not limited to document receipt, scanning, quality control, naming, upload and filing.
• Assists in periodic quality controls of the eTMF in compliance with study specific TMF plans.
• Ensures continuous audit/inspection readiness and completeness of the eTMF.

SCTA General office and meeting logistics

Prepare the meeting logistics as dictated by Office Management (preparation of the meeting room, serve the catering, preparation of the morning coffee for all employees, etc.)

Mentor, train and coordinate other CTAs and/or CTA Trainees

Required profile:

• High School certificate.
• Experience in administrative area at CRO or a Pharmaceutical Company for a minimum of 5 years is desirable.
• High knowledge of GCPs/ICH and local/international regulations is desirable.
• Organizational and planning skills.
• Intermediate or high level of spoken and written English.
• Good knowledge of current PC-applications.
• Highly committed and ability to work under pressure.
• Team player and very good communications skills.
• Empathy and ability to establish good relationships with others.

What You Can Expect:

• Career growth resources and flexible work schedules.
• Training to enhance therapeutic knowledge.
• Exposure to dynamic work environments and new experiences

Commitment to Equal Opportunity:

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.