Optional module to communicate news. It can work in carousel format. Link
Optional module to communicate news. It can work in carousel format. Link
Optional module to communicate news. It can work in carousel format. Link
Work with us
Job Offers
Medical Monitoring Manager – Freelance – Remote Spain
The Medical Monitoring Manager will provide independent medical oversight across assigned clinical trials, ensuring consistent medical guidance at subject and study level. The role supports clinical safety, protocol compliance, and high quality data generation throughout the lifecycle of the study.
At QualitecFarma, we partner with biotech and pharmaceutical innovators to deliver high quality, agile clinical research across Europe and beyond. Our model combines operational excellence, and hands on collaboration with sponsors and sites allowing us to move fast without compromising patient safety or data integrity.
As we continue to expand our clinical operations in Spain, we are strengthening our in house medical oversight capability. The Medical Monitoring Manager plays a pivotal role in ensuring consistent, independent medical judgement across studies This role will be central to our commitment to subject safety, protocol integrity, and regulatory compliance, while acting as a trusted medical partner to sponsors, sites, and internal teams.
The Medical Monitoring Manager will provide independent medical oversight across assigned clinical trials, ensuring consistent medical guidance at subject and study level. The role supports clinical safety, protocol compliance, and high quality data generation throughout the lifecycle of the study.
Acting as the primary medical point of contact for sites, sponsors, and internal teams, the Medical Monitoring Manager collaborates closely with Clinical Operations, Data Management, and safety, to identify risks early, support sound medical decision making, and maintain regulatory and ethical standards.
Duties required:
Provide medical expertise on protocol development
Provide medical expertise and guidance on protocol interpretation, patient eligibility, and investigational product related questions
Serve as the medical authority for addressing protocol and unforeseen clinical scenarios during trial conduct
Review and assess individual and cumulative safety data, including laboratory values, adverse events, and protocol deviations, in accordance with study specific plans. Attendance to Data Safety
Management Board (DSMB), when applicable
Identify emerging safety trends and escalate concerns appropriately in collaboration with Safety and Sponsor Medical teams
Provide medical input into decisions regarding unblinding, subject management, and safety follow-up
Develop, review, and implement study specific Medical Monitoring Plans where applicable
Provide medical review of the Clinical Study Report (CSR)
Study & Data Review
Conduct medical review of adverse events, safety data, and benefit-riskassessments
Provide medical review of study level data to identify gaps, inconsistencies, or areas requiring additional safety follow up
Support review of data listings throughout the study and contribute to interim and final data analyses as required
Participate in the development, review, and finalisation of protocols, amendments, Clinical Study Reports, and other key study documents
Provide medical input into data collection tools, monitoring strategies, and statistical or operational study plans
Cross Functional & Sponsor Collaboration
Act as a medical liaison between QualitecFarma internal teams, clinical sites, and sponsor medical groups
Participate in and lead medical monitoring teleconferences and safety discussions at regular intervals
Consult with Sponsor Medical representatives and internal Medical/Safety leadership on indication or compound specific issues
Document all medical contacts and decisions in accordance with QualitecFarma SOPs and study specific procedures
Training & Knowledge Sharing
Contribute to the development and maintenance of medical and therapeutic training materials
Deliver internal medical training to Clinical Operations and project teams on disease areas, compounds, pharmacology, and protocol requirements, if needed
Support investigator and CRA training activities, including investigator meetings and study initiation meetings, as required
Knowledge & Expertise
Maintain in depth knowledge of assigned protocols and Investigator Brochures, with a particular focus on subject safety and risk mitigation
Apply sound clinical judgement and analytical thinking to complex datasets to support subject protection and data quality
Ensure alignment with ICH-GCP, applicable EU regulations, and local clinical research requirements
Education and skills required:
Medical Degree (MD or equivalent)
Minimum 5–7 years experience in clinical research, pharmaceutical, biotech, or CRO environment
Strong understanding of drug development, ICH-GCP, and clinical trial conduct
Proven ability to exercise independent medical judgement in complex clinical scenarios
Previous experience working within a CRO environment is highly desirable
Excellent written and verbal communication skills, with confidence interacting with sponsors, investigators, and cross-functional teams
Fluent English required
Why Join QualitecFarma
Be part of a growing, science driven CRO with strong European presence
Work closely with senior clinical leadership and global sponsors
Influence study quality and patient safety at a strategic level
Flexible working model
Recruitment Agency Disclaimer
QualitecFarma does not accept unsolicited CVs from recruitment agencies. Any CVs submitted without a signed agency agreement will be considered the property of QualitecFarma, and no fees will be payable
Regulatory Affairs Manager
Supervise and coordinate the execution of formulation, manufacture, dossier construction, registration of products. Also supervise the registration of companies, where applicable. Coordinate junior staff.
Assist on products registration (human medicines, medical devices, cosmetics, food supplements, etc), variations, renewals, or any other activity regarding the maintenance of the dossiers (e.g., readability tests). These procedures could be National or European procedures (Centralized, Decentralized and Mutual Recognition Procedures).
Ensure regulations compliance (on both European and local regulations).
eCTD compilation
Collect and evaluate scientific data.
Prepare labelling, PIL, SmPC and mockups of medicinal products, and adaptation to current QRDs.
Provide strategic advice throughout the development of new products.
Managing teams of colleagues involved with the development of new dossiers.
Keeping abreast of international legislation, guidelines, and customer practices in all countries that the company is working.
Advise clients and manufacturers on regulatory requirements.
Work with specialist computer software and resources (eCTDmanager, Lorenz Validator, RAEFAR, etc).
Negotiate with regulatory authorities for marketing authorisation, variations, or any other required activity for the approval of medicinal products in Spain and other countries, as needed.
Education and skills required:
B.Sc degree in life science (Chemistry, Biology, Pharmacy, etc).
Master or related course in Regulatory Affairs will be desirable.
English level: High (spoken and written).
CTA
A Clinical Trial Assistant (CTA) will manage administrative tasks throughout the life stages of a clinical trial, supporting the QF Local Study Team with the submission, collecting, listing, maintaining, tracking and updating (as corresponds) of trial related documentation; being a relevant liaison with other parties of the clinical study (Health Authorities, research sites, CRAs and Sponsor, when applicable).
Supporting, the Local Study Team collecting and tracking the documents and data required for regulatory
submissions (contracts, financial agreements, patient informed consent forms, insurance certificates).
Performing study submission to Health authorities, initial, amendments, notifications, etc.
Maintaining and updating of the Trial Master File and preparation for relevant QC checks when applicable
Tracking site budget related matters, including processing invoices, tracking payments and for scheduling meetings, updating Excel trackers, coordinating the translation of site documents.
Train CTA trainees, if applicable.
Education and skills required:
Postgraduate studies or course of Clinical Trial Assistant (or equivalent), ongoing or finished.
Good command of written English.
Excellent organizational and prioritization skills.
Knowledge of Microsoft Office programs.
Attention to detail and excellent oral and written communication skills.
Senior CRA
Participate in pre-trial procedures, archiving documents and correspondence, setting up and organizing clinical trial sites, perform on-site visits and training and mentoring of CRAs with less experience. Supporting activities to CTM regarding project management.
Perform site selection, SIV, IMV and COV in clinical studies of new and established pharmaceuticals. Experience in oncology trials is highly valued.
Responsible for support and management of sites to ensure that projects are conducted in accordance with protocol, applicable regulation, and the latest ICH guidelines.
Obtain, maintain and review applicable clinical documentation in a timely manner.
Prepare and attend investigator meetings.
Participate in hosting pertinent audits/inspections when necessary.
Training and mentoring of CRAs with less experience.
Eventual support in the writing of company procedures.
Education and skills required:
Degree in life sciences or equivalent.
Master of Clinical Trials Monitoring.
Proven track record as an accomplished CRA in IMP trials (at least 4 years).
English: Fluent spoken & written.
Excellent communication and time management skills to manage multiple projects at any one time.
Strong team member and understand the need for effective communication at all levels.
Effective relationship building with sponsors, sites and colleagues, as well as strong management skills.
Responsible person, able to work with autonomy, dynamic and well organized.
Must be able to travel in accordance with company and project requirements.
CRA
Participate in pre-trial procedures, archiving documents and correspondence, setting up and organizing clinical trial sites and perform on-site visits.
Perform in site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation.
Support and management of the sites to ensure that projects are conducted in accordance with protocol, applicable regulation, and the latest ICH guidelines.
Managing progress by tracking case report form (CRF) completion and data query resolution.
Evaluating the quality and integrity of site practices – escalating quality issues as appropriate.
Cooperating and/or writing study plans and manuals.
Education and skills required:
Bachelor’s degree, or equivalent, in a scientific or healthcare discipline.
Master of Clinical Trials Monitoring.
Understanding of SOPs, WIs, EU, and local regulations as well as ICH GCP guidelines.
Good command of written and spoken English language.
Computer skills including use of Microsoft Word, Excel, and PowerPoint.
Willingness and ability to travel.
Responsible person, dynamic and organized, good team player.
Looking for
a traineeship
or an internship
with us?
No traineeships or internships available at the moment.
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent.
This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
