Clinical Documentation Specialist

hace 2 días


Madrid, Madrid, España Tfs Healthscience A tiempo completo

About Tfs Healthscience
Tfs Healthscience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing and functional service solutions.

Job Overview
We are seeking a highly experienced Clinical Documentation Specialist to join our Medical Writing Department within Project Delivery. This role will involve working independently on preparing and completing clinical and regulatory documentation in assigned Study Teams, according to company policies, SOPs and regulatory requirements.

Key Responsibilities
The successful candidate will have a broad and long experience of all matters within medical writing and will be responsible for:
• Writing and reviewing synopsis and Clinical Study Reports/Clinical Investigation Reports
• Preparing protocols, monographs, patient narratives, and manuscripts for journal publications
• Reviewing of Statistical Analysis Plans
• Co-ordinating the TFS Report Writing Team
• Writing and reviewing Clinical Study Protocols/Clinical Investigation Plans and Subject Information
• Writing and reviewing Investigator's Brochures/Clinical Investigator's Brochures
• Writing and reviewing Investigational Medicinal Product Dossiers
• Writing and reviewing clinical summaries and overviews
• Writing and reviewing publications
• Translating/correcting clinical and regulatory documents
• Actively contributing to the organization and development of routines to enhance the work at TFS
• Writing and reviewing abstracts/posters
• Literature review
• Participating in client meetings regarding project-related issues
• Coaching and supporting Medical Writers
• Advising clients and other Units in methodological and scientific aspects of studies
• Contacting Key Opinion Leaders and Medical Experts working as external consultants

Qualifications
To be considered for this role, you will need:

  • A Bachelor's Degree or relevant experience
  • 4-5 years of relevant experience
  • Knowledge of medical terminology
  • Excellent writing, editing and organizational skills
  • Excellent verbal and communication skills
  • Proficiency in word processing software

What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. Based on industry standards, we estimate an annual salary of $85,000-$110,000, depending on location and experience.

About Us
Tfs Healthscience has been delivering tailored clinical research services in more than 40 countries for over 27 years. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, we deliver flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.



  • Madrid, Madrid, España Tfs Healthscience A tiempo completo

    About this role: TFS HealthScience is a leading global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities and flexible clinical development solutions across key therapeutic areas. As a Clinical Documentation...


  • Madrid, Madrid, España Tfs Healthscience A tiempo completo

    Company Overview: TFS HealthScience is a global Contract Research Organization founded over 27 years ago in Lund, Sweden. We offer flexible, solution-driven clinical research services in key therapeutic areas.We have more than 800 professionals across 40 countries, providing innovative solutions and a commitment to quality. Our core values guide us in...


  • Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo

    At Syneos Health, we are passionate about developing innovative solutions to accelerate the delivery of therapies. As a Clinical Development Specialist, you will play a critical role in supporting the planning and execution of Pre-Approval Access (PAA) Programs.About the RoleThis is an exciting opportunity to join our team in Barcelona, where you will be...


  • Madrid, Madrid, España Worldwide Clinical Trials A tiempo completo

    Estimated Salary: $120,000 - $180,000 per yearAbout the Role:We are seeking a highly skilled Clinical Trials Specialist to join our team at Worldwide Clinical Trials. As a key member of our organization, you will play a critical role in advancing new medications and therapies for patients worldwide.About Us:As a leading global contract research organization...


  • Madrid, Madrid, España Icon A tiempo completo

    About the RoleWe are seeking a highly skilled Senior Medical Writer to join our team at ICON. As a key member of our clinical documentation team, you will be responsible for writing and editing high-quality clinical documents in support of regulatory submissions.Key ResponsibilitiesDevelop and implement clinical content strategies for assigned projectsAuthor...


  • Madrid, Madrid, España Icon Clinical Plc A tiempo completo

    Lead the Way in Clinical Data StandardsWe are a leading healthcare intelligence and clinical research organization, shaping the future of clinical development.This is an opportunity to work with our team as a Senior Clinical Data Specialist. As a key member, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical...


  • Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo

    Syneos Health seeks a Clinical Content Specialist.As a key member of the Medical Writing department, this role is responsible for mentoring and leading less experienced medical writers on complex projects. The ideal candidate will have strong communication skills to effectively represent the team on clinical study teams, at conferences, meetings, and...


  • Madrid, Madrid, España Doit A tiempo completo

    Cloud Documentation SpecialistAt DoiT, we're looking for a skilled Cloud Documentation Specialist to join our UX/UI team in EMEA. As a Cloud Documentation Specialist, you will be responsible for creating, updating, and maintaining customer-facing documentation at DoiT Help Center and the Developer Hub. You will work closely with our talented team of product...


  • Madrid, Madrid, España Iqvia A tiempo completo

    Job OverviewWe are seeking a skilled Clinical Devices Integration Specialist to join our team at IQVIA.The ideal candidate will have a strong background in clinical trials and eSource platforms, with experience in connected devices and data management.About the RoleThis is a challenging opportunity to work on business requirement understanding, test case...


  • Madrid, Madrid, España Undisclosed A tiempo completo

    **Overview of the Role:**We are seeking an experienced Senior Clinical Data Specialist to join our dynamic team. The ideal candidate will be responsible for overseeing the programming and validation of clinical trial databases, ensuring data accuracy, integrity, and compliance with regulatory standards.**Responsibilities and Duties:Database Programming: Lead...

  • Clinical Specialist

    hace 4 semanas


    Madrid, Madrid, España STERIS A tiempo completo

    At STERIS, we empower our customers to deliver exceptional patient care by providing innovative healthcare solutions worldwide.Job Summary:We are seeking a Clinical Specialist to join our team, responsible for serving as a subject matter expert on clinical and product knowledge. This role will support customers in utilizing STERIS solutions, explaining...


  • Madrid, Madrid, España Icon Clinical Plc A tiempo completo

    Role OverviewWe are seeking a highly skilled Outcomes Researcher to join our team at ICON Clinical Plc. This role will involve leading strategic discussions and trainings related to the incorporation of digital measures and digital health technologies (DHTs) into clinical trial protocols using HumanFirst's Atlas software solution.Key ResponsibilitiesClient...


  • Madrid, Madrid, España Innovative Trials A tiempo completo

    Job Title: Clinical Trials Optimisation Specialist - SpainAbout the Role:Innovative Trials is seeking a highly motivated and experienced Clinical Trials Optimisation Specialist to join our team in Spain. As a Clinical Trials Optimisation Specialist, you will play a crucial role in boosting patient recruitment for our clients' clinical trials.About the...


  • Madrid, Madrid, España Worldwide Clinical Trials A tiempo completo

    We are Worldwide Clinical Trials, a global CRO that pushes boundaries and innovates to advance clinical research. As a Clinical Research Associate II, you will be part of a team of over 3,500 experts dedicated to improving lives.Clinical Operations at WorldwideYou will work alongside brilliant minds across various therapeutic areas, including Cardiovascular,...


  • Madrid, Madrid, España Doit A tiempo completo

    About the RoleWe are seeking a skilled Cloud Documentation Specialist to join our team at DoiT. This role is based remotely in Spain and is an integral part of our UX/UI team in EMEA. As a Cloud Documentation Specialist, you will be responsible for creating, updating, and maintaining customer-facing documentation at DoiT Help Center and the Developer...


  • Madrid, Madrid, España Innovative Trials A tiempo completo

    **Job Overview**Innovative Trials is seeking a highly skilled Clinical Trials Optimization Specialist to join our team in Spain. As a key member of our clinical operations team, you will play a crucial role in driving patient recruitment and retention for our clients' clinical trials.**Key Responsibilities**We are looking for an experienced professional with...


  • Madrid, Madrid, España Icon Clinical Plc A tiempo completo

    About the RoleYou will play a key part in shaping the future of clinical development at ICON Plc, a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment that drives innovation and excellence, and we welcome talented individuals to join us on this mission.As a Clinical Data Standards Consultant, you will...


  • Madrid, Madrid, España Worldwide Clinical Trials A tiempo completo

    About UsWe're a global, mid-sized Contract Research Organization (CRO) that fosters innovation and excellence in clinical trials. Our mission is to improve lives by working with passion and purpose every day. At Worldwide Clinical Trials, we're committed to a diverse and inclusive environment that promotes collaboration and creativity.Our TeamWe're a global...


  • Madrid, Madrid, España Amazon A tiempo completo

    Amazon is seeking an experienced Senior Documentation Specialist to join our team. The estimated salary for this role is $85,000 - $110,000 per year, depending on location and experience.About the RoleWe are looking for a skilled content developer who can create and edit helpful process documents. As a Senior Documentation Specialist, you will work with...


  • Madrid, Madrid, España The Cigna Group A tiempo completo

    As a Global Clinical Support Specialist, you will be instrumental in supporting our global clinical team with day-to-day emergency assistance and evacuation requests.You will address your duties with a sense of urgency to ensure all internal and external parties are briefed with the most relevant information, as well as cases being documented to the highest...