Career Portal

Become a Clinical Research – or Regulatory Affairs Scientist

• POSITION TITLE: Fellow Scientist
• DEPARTMENT: Clinical Affairs and Regulatory Affairs
• CLASSIFICATION: Apprentice contract (paid)
• PLACE OF WORK: Office-based (San Sebastian de los Reyes | Madrid)

The Fellows Program is an excellent opportunity for graduates in life sciences, medicine, and pharmacy to become a part of the fascinating medical device industry. Our fellows’ program provides rigorous and comprehensive training in all areas of clinical research, regulatory affairs, and medical device development. This is a paid apprentice position and is an excellent opportunity to learn a profession and find an entry point in a dynamic and exciting industry.

Over nine months, fellows participate in course work, interactive learning, and extensive on-the-job training. Fellows are strategically assigned to projects to maximize clinical research and device development exposure. As we feel mentorship is an essential part of the program, all fellows are assigned a mentor and receive additional support and guidance from our scientists and industry experts. 

Coursework and interactive learning consist of master classes given by our subject matter experts and opportunities to attend all in-house training on preparing technical documentation, clinical investigation planning, clinical monitoring, clinical trial biostatistics, clinical data management, good clinical practice principles, and medical device development strategies.

Project work may entail many different activities, including device development plans, protocol design, technical and regulatory documentation, project plan development, and clinical trial management. To provide the toolset needed for a career in medical device development, all fellows undergo project management training and are encouraged to take on leadership roles as their skills dictate. This unique experience allows maximized exposure to clinical research, regulatory affairs, and medical device development practices. 

This unique experience allows for maximized exposure to clinical research, regulatory affairs, and medical device development practices. At the end of the program, fellows that have successfully completed the program are encouraged to apply for a position in the company.

ON-THE-JOB TRAINING

• Support preparation of clinical protocols and case report forms
• Support regulatory and ethics committee submissions
• Support development of MDR and IVDR regulatory documents
• Support preparation of site monitoring documents
• Support preparation of essential clinical documents
• Liaise with assigned clinical sites and collect GCP documentation

POSITION QUALIFICATIONS

• Bachelor’s degree in life sciences or pharmacy
• Advanced degree (Masters, Ph.D. or M.D.)
• Familiarity with the hospital environment
• English (advanced and full professional proficiency)
• Spanish (working proficiency)
• Third language such as German or French is preferred

Apply here: AKRN Fellows Program

Clinical Research Associate

• POSITION TITLE: Clinical Research Associate (CRA)
• DEPARTMENT: Clinical Affairs
• CLASSIFICATION: Full-time Employment 
• LEVEL: Entry level
• PLACE OF WORK: Office-based (Madrid)

POSITION SUMMARY

Under the direction of the Clinical Affairs Manager, the CRA will implement and coordinate assigned projects; pre-market (CE mark) and post-market( PMCFs) studies Europe, related to medical devices. The CRA will perform the job according to internal and external requirements, including European medical device regulation and national guidelines. The job duties involve managing all aspects of submissions to Ethics Committees; clinical trial contract negotiations; case report form (CRF) design and implementation; database management (data collection, review and query); clinical on-site monitoring; maintaining close contact with study site coordinators and investigators; and participating in congresses and external meetings as required. 

KEY RESPONSIBILITIES

• Manage initiation of clinical sites including regulatory and ethics committee submissions, and applicable training of site on protocol and CRF
• Ensures adequacy of regulatory documents and compliance with regional and national requirements. 
• Monitoring and reporting of site enrollment progress 
• Maintaining site and internal documentation in accordance with established SOPs
• Ensuring clinical study contract obligations are met in a timely manner
• Serving as key contact for assigned clinical sites throughout the study
• Perform other related duties as assigned on request

POSITION QUALIFICATIONS

• Experience in clinical research
• Excellent computer proficiency (Microsoft® Office); 
• Good communication, organizational, and time management skills 
• Self-motivation with the ability to work under pressure to meet deadlines 
• Knowledge of GCP, ISO 14155 and clinical monitoring procedures
• Bachelor’s degree in life sciences 
• Familiarity with hospital environment
• English (advanced), Spanish, and third language such as German, French, or Portugueese
• Willingness to travel up to 40%

Apply here: Clinical Research Associate (entry level)

Become a Clinical Study Manager

• POSITION TITLE: Clinical Study Manager
• DEPARTMENT: Clinical Affairs and Regulatory Affairs
• CLASSIFICATION: Apprentice contract (paid)
• PLACE OF WORK: Office-based (San Sebastian de los Reyes | Madrid)

JOB SUMMARY

Under the direction of the Clinical Affairs Manager, the Clinical Study Manager will implement, and coordinate assigned clinical studies and projects primarily related to medical device products. The overall scope of the role is to plan, execute, maintain oversight and report on clinical investigations, from planning, vendor selection (if applicable) and site selection, site initiation, site monitoring and site closeout. Lead and provide direction to the cross-functional Study Management Team to ensure all study outputs from protocol development to final clinical study report (including archiving of the Trial Master File) are delivered on time, within budget, and with high quality, in adherence to internal SOPs, GCP and applicable regulatory guidelines.

RESPONSABILITIES

• Setting targets for clinical monitoring staff, and ensuring the execution of clinical investigations in compliance with project goals and Regulations and GCP guidelines.
• Creating and implementing study-specific clinical monitoring tools and documents.
• Creating and overseeing development clinical essential documents (such as CIP, ICF, CRF).
• Identifying and choosing sites, and coordinating site management activities.
• Coordinating and supervising clinical monitoring team.
• Providing CRAs with project-specific training and having regular meetings with them.
• Recording and sharing interactions with clients, and acting as Sponsor representative.
• Assuring compliance with SOPs and local regulations, and ICH GCP, ISO 14155 GCP
  • Oversee Regulatory and Ethics Committee submissions
  • Contribute to the development of regulatory documents and responses to Health Authority and Ethics Committee
  • Oversee adequacy of regulatory documents and in compliance with EC requirements.
  • Ensure study team members are timely informed, trained and updated on their role and responsibilities through-out the duration of the study
  • Provide study specific direction to study team members and ensure that they are regularly updated on the study progress, challenges and risks through-out the duration of the study
  • Ensure project is assigned a key contact throughout the study
  • Implement best practices and lessons learned and share outcome with the teams
  • Oversee database lock activities to ensure timely data availability and coordinate study close out

QUALIFICATIONS/REQUIREMENTS

• Experience as in Clinical Research Scientist (2 to 5 years).
• Experience with Medical Devices.
• Excellent communication, interpersonal and networking skills.
• Pro-active and problem-solving attitude, very strong prioritization skills.
• Self-motivation, able to work independently as well as on cross-functional teams.
• Excellent planning and organizing skills.
• Personal resilience, perseverance, energy and drive.
• Team player, collaborative attitude.
• Working knowledge of EU MDR / local regulations / ISO14155, device development, and clinical monitoring procedures.

MINIMUM EDUCATION AND EXPERIENCE

• Bachelor’s degree in life sciences.
• Advanced degree (Masters or PhD) preferred.
• Demonstrated project management experience and leadership skills (e.g., leading project teams) working in global cross-functional (matrix) and multicultural teams.
•  Experience in managing complex studies (e.g., large studies, difficult patient populations involvement of many external service providers).
• Experience in executing a wide range of clinical study activities (from initiation to clinical study report)

SKILLS

• English (advanced)
• Spanish (working proficiency)
• Third language such as German or French is preferred

Apply here: Clinical Study Manager (experienced)

Clinical Study Manager

• POSITION TITLE: Clinical Study Manager (CSM)
• DEPARTMENT: Clinical Affairs
• CLASSIFICATION: Full-time Employment 
• LEVEL: Entry level
• PLACE OF WORK: Office-based (Madrid)

POSITION SUMMARY

Under the direction of the Clinical Affairs Manager, the CSM will implement and coordinate assigned projects; pre-market (CE mark) and post-market (PMCFs) studies Europe, related to medical devices. The CSM will perform the job according to internal and external requirements, including European medical device regulation and national guidelines.. The job duties involve managing all aspects of submissions to Ethics Committees; clinical trial contract negotiations; case report form (CRF) design and implementation; database management (data collection, review and query); maintaining close contact with study site coordinators and investigators; and participating in external meetings as required. 

KEY RESPONSIBILITIES

• Preparation of clinical protocols (and amendments), clinical trial contracts (and amendments), and case report forms
• Oversee initiation of clinical sites including regulatory and ethics committee submissions, and applicable training of site on protocol and CRF
• Oversee collection of regulatory documents and compliance with regional and local requirements. 
• Reporting of study and site progress 
• Ensuring project milestones are met
• Serving as key contact for assigned project

POSITION QUALIFICATIONS

• Experience in clinical research (min 2 years)
• Experience with medical devices 
• Excellent computer proficiency (Microsoft® Office); 
• Good communication and organizational / time management skills 
• Self-motivation with the ability to work under pressure to meet deadlines 
• Detail and process-oriented, positive attitude and approach, multi-tasking capability 
• Working knowledge of EU Medical Device Regulation / ISO14155, device development, and clinical monitoring procedures
• Bachelor’s degree in life sciences 
• Advanced degree (Masters or Ph.D.) preferred.
• Familiarity with the hospital environment
• English (advanced), Spanish, and third language such as German, French, or Portugueese

Apply here: Clinical Study Manager (entry level)

Medical Writer

• POSITION TITLE: Medical Writer
• DEPARTMENT: Clinical and Regulatory Affairs
• CLASSIFICATION: Full-time Employment 
• LEVEL: Entry level
• PLACE OF WORK: Office-based (Madrid)

POSITION SUMMARY

Under the direction of the Clinical Affairs Manager or Regulatory Affairs Manager the medical writer will support the development of several key clinical and regulatory documents.

KEY RESPONSIBILITIES

• Support preparation of clinical literature reviews
• Support development of clinical and performance evaluation reports
• Support preparation of post-market documentation
• Support preparation of summaries of clinical safety and performance
• Participate in the preparation of white papers, scientific publications and conference abstracts

POSITION QUALIFICATIONS

• Bachelor’s degree in life sciences, medicine or pharmacy
• Advanced degree (preferably Ph.D. or M.D.)
• Medical Writing experience (peer-reviewed journal publications, book chapters, PhD thesis)
• English (advanced and full professional proficiency)
• Spanish (working proficiency)
• Candidates with a third language, such as German or French, will be fast-tracked

Apply here: Medical Writer (entry level)

Senior Biostatistician

• POSITION TITLE: Senior Biostatistician
• DEPARTMENT: Clinical Affairs
• CLASSIFICATION: Full-time Employment 
• PLACE OF WORK: Office-based (Madrid)

JOB DESCRIPTION

• Serve as statistician for research studies.
• Author Statistical Analysis Plans.
• Provide data analysis, tables and graphics for statistical reports provided to researchers and Medical Research Managers.
• Prepare datasets for analysis by merging files, creating analysis variables, editing data, and developing documentation.
• Interpret results of analysis for a wide variety of audiences.
• Contribute to the design and use of appropriate data collection and quality control methods.
• Promote good statistical practice for the support of sound scientific judgments.
• Perform project in compliance with regulations.
• Develop positive relationships with clients, as well as with NAMSA colleagues.
• Function at a level that affords respect by internal NAMSA Associates/team members.
• Ensure schedule, budget and quality commitments are met for the client, within the scope of control.
• Communicate project/team issues to project Medical Research Manager and/or NAMSA C&C Management.
• Handle challenging situations, communicate to project Medical Research Manager, and know when to call-in help.
• Contribute to presentations, including preparation, assembling slides, and speaking.
• Interact as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
• Participate in meetings with prospective clients.
• Provide scope of project and relevant information to support the creation of proposals.
• Offer opportunities to clients for expansion of MRO services to be provided by NAMSA.
• Determine statistical support requirements, negotiate timelines and coordinate work of statistical team supporting research projects.
• Prepare Statistical Analysis Plans, table shells, analysis specifications, and statistical reports; conduct statistical programming primarily in SAS; oversee validation process.
• Prepare datasets for analysis by merging files, creating analysis variables, editing data, and developing documentation.
• Prepare statistical sections of protocols, study reports and manuscripts, and review these documents for accuracy and appropriate interpretation.

QUALIFICATIONS & TECHNICAL COMPETENCES

• Bachelor’s degree or equivalent experience in a related field, and a minimum of 8 years of relevant experience; or
• Master’s or Doctorate degree in Biostatistics, Statistics, Epidemiology, Applied Math (or similar) or equivalent experience in a related field, and a minimum of 4 years of relevant experience.
• Fluency in English and local language, if different, required.
• Knowledge and experience with SAS programming language.
• Ability to organize and manipulate large datasets.
• Ability to express complex statistical concepts and technical information to researchers.

WORKING CONDITIONS

• Physical activities include walking, sitting and standing for prolonged periods.
• Extensive use of computer keyboard and mouse.

Apply here. Senior Biostatistician

Senior Statistical Programmer

• POSITION TITLE: Senior Statistical Programmer
• DEPARTMENT: Regulatory Affairs
• CLASSIFICATION: Full-time Employment 
• PLACE OF WORK: Office-based

JOB DESCRIPTION

• Perform the work of statistical programming services to achieve quality, timely and cost-effective study deliverables.
• Prepare datasets for analysis by merging files, creating analysis variables, editing data, and developing documentation.
• Remain informed of new developments in statistical programming that are relevant to the industry and support to the innovation of new reporting systems.
• Support the creation of statistical programming standards that comply with regulatory requirements, and increase efficiency and quality across studies.
• Contribute to the creation of standard macros and/or tools in SAS for data analysis and reporting.
• Assist with statistical quality assurance review.
• Contribute to the design and use of appropriate data collection and quality control methods.
• Mentor and train selected Associates within the Biostatistics and Data Management department.
• Perform project in compliance with regulations.
• Develop positive relationships with clients, as well as with NAMSA colleagues.
• Function at a level that affords respect by internal NAMSA Associates/team members.
• Ensure schedule, budget and quality commitments are met for the client, within the scope of control.
• Communicate project/team issues to project Medical Research Manager and/or NAMSA C&C Management.
• Handle challenging situations, communicate to project Medical Research Manager, and know when to call-in help.
• Contribute to presentations, including preparation, assembling slides, and speaking.
• Interact as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
• Participate in meetings with prospective clients.
• Provide scope of project and relevant information to support the creation of proposals.
• Offer opportunities to clients for expansion of MRO services to be provided by NAMSA.
• Serves as lead when conducting the work of statistical programming services to achieve quality, timely and cost-effective study deliverables.
• Provide strategic support regarding statistical programming methodology.
• Contribute to statistical programming standards that comply with regulatory requirements, and increase efficiency and quality across studies.
• Develop and/or contribute to the creation of standard macros and/or tools in SAS for data analysis and reporting.
• Propose creative solutions to identified problems.

QUALIFICATIONS & TECHNICAL COMPETENCES

•  Bachelor’s degree or equivalent experience in a related field, and a minimum of 5 years of relevant experience; or
• Master’s or Doctorate degree in Biostatistics, Statistics, Epidemiology, Applied Math (or similar) or equivalent experience in a related field, and a minimum of 2 years of relevant experience.
• Experience with SAS programming projects in the pharmaceutical or medical device industry demonstrated by the ability to independently act as the point of contact on the statistical programming for all phases of clinical trials.
• Fluency in English and local language, if different, required.
• Knowledge and experience with SAS programming language.
• Ability to organize and manipulate large datasets.
• Ability to express complex statistical programming concepts and technical information. 

WORKING CONDITIONS

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms.  The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
• Extensive use of a computer keyboard.

Apply here. Senior Statistical Programmer

Regulatory Affairs

• EMPLOYEE: Ariadna Navarro
• DEPARTMENT: Regulatory Affairs
• PLACE OF WORK: Office-based (San Sebastian de los Reyes, Madrid) 

Clinical Research

• EMPLOYEE: Ruben Ruiz
• DEPARTMENT: Clinical Affairs
• PLACE OF WORK: Office-based (San Sebastian de los Reyes, Madrid)