Clinical affairs managers play an essential role in demonstrating the safety, performance, and benefits of a medical device. They operate at the interface between science and regulation.
This article sheds light on the multifaceted role of these experts: tasks and challenges, as well as earning and career opportunities.
1. Tasks of clinical affairs managers
Clinical affairs managers are responsible for planning, monitoring, and controlling medical devices’ entire clinical evaluation process.
Their work is crucial for demonstrating the safety and performance of a medical device. This evidence is a prerequisite for the approval of devices by regulatory authorities such as the FDA in the USA, notified bodies in Europe, and the BfArM in Germany.
1.1 Develop clinical strategies
The clinical affairs managers determine the clinical strategy in coordination with the management, the product managers, and the regulatory affairs managers. In doing so, they create the conditions for fast, plannable, and cost-effective approval.
For example, the clinical affairs managers help to formulate the intended purpose and the “medical claims” in such a way that
- clinical data from predecessor or benchmark devices are used as effectively as possible,
- complex clinical investigations are avoided, or their scope is minimized,
- coordination within the company and with customers and authorities is optimized,
- and problems with approval, unnecessary costs, and delays are avoided as much as possible.
1.2 Create clinical evaluations
Clinical affairs managers are involved in all processes relating to the clinical evaluation and use of medical devices. From brainstorming and development to market entry, they are key players who ensure that all steps are scientifically sound and compliant with regulations.
They plan the necessary activities and document them in the clinical evaluation plans. They compile and evaluate the evidence in the clinical evaluation reports.
1.3 Carry out literature research (also for special product groups)
Literature research is an important part of clinical evaluation. The clinical affairs managers research and evaluate information, including
- on the state of the art,
- on equivalent products,
- and on the safety and performance of their own and other devices and procedures.
Substance-based medical devices, such as nasal sprays or surgical adhesives, must prove that their effect is purely physical and not due to immunological, pharmaceutical, or metabolic processes. Verifying this requirement requires a comprehensive and systematic literature search on the mechanisms of action of the respective substances. This ensures that the devices actually work in the intended physiological way.
This is where the expertise of clinical affairs managers comes into play: they use their scientific expertise to provide support through detailed analyses and assessments. These professionals are essential to properly evaluate and respond to specific inquiries across the organization, contributing significantly to the safety and effectiveness of medical devices.
1.4 Orchestrate clinical investigations
Clinical affairs managers must provide the necessary evidence that the medical devices are safe and effective. The provision of evidence includes clinical studies or clinical investigations in accordance with ISO 14155.
Clinical affairs managers ensure that studies comply with ethical standards and legal requirements.
They formulate the study’s objectives, such as the clinical endpoints, plan the study, and commission and monitor Clinical Research Organizations (CROs) as required.
Clinical affairs managers also document the scientific output of studies and, if necessary, publish them.
1.5 Monitore devices after market launch
The tasks of clinical affairs managers do not end with the approval of the devices. Instead, they are responsible for continuously monitoring the device and conducting Post-Market Clinical Follow-up (PMCF) activities. These serve to collect and evaluate long-term safety and performance information.
1.6 Support the colleagues
The risk management team
Clinical affairs managers conduct systematic literature searches to determine probabilities of hazards and risks for the product group. This process not only helps to identify new risks but also to update the frequencies of already known risks. Such findings are essential to ensure that the devices are both safe and effective and comply with regulatory requirements.
The own team
Clinical affairs managers use their expertise to support and relieve their colleagues in all matters relating to clinical investigations, clinical evaluations, literature searches, and regulatory requirements. They ensure that the team’s knowledge of current regulations is always up to date, thus promoting efficient and effective work.
1.7 Ensure regulatory compliance in the long term
With the introduction of the Medical Device Regulation (MDR) in the EU, the requirements for collecting and evaluating clinical data have been significantly tightened. Clinical affairs managers must understand and implement these increased requirements to ensure their devices are compliant.
They must also continuously monitor and evaluate changes to regulatory requirements worldwide.
Several hundred medical device manufacturers’ clinical and regulatory affairs managers have outsourced this regulatory monitoring to the Johner Institute.
2. Competencies of clinical affairs managers
Core competencies include an in-depth understanding of clinical research processes, regulatory knowledge, and project management and communication capabilities. In order to be successful as a clinical affairs manager, a comprehensive profile of specialist knowledge, experience, and soft skills is required.
2.1 Scientific and medical competencies
Clinical affairs managers should generally have a medicine, biology, pharmacy, or chemistry degree. Ideally, they should have a doctorate, as a sound scientific education is essential for scientific work.
Understanding the complexity of development processes, clinical investigations, and regulatory requirements is also necessary. A PhD can signal further specialization and depth in a relevant area, which is a great advantage in this role.
Through their studies and qualifications, clinical affairs managers also have the necessary medical and scientific expertise to fulfill their tasks in the clinical evaluation and monitoring of medical devices.
2.2 Regulatory expertise
Clinical affairs managers need to grasp the extensive global regulatory requirements and know how to meet them to get devices approved without incurring unnecessary costs.
2.3 Device and market knowledge
Working as a clinical affairs manager requires extensive knowledge of the national and international market as well as the competition. After all, to develop effective strategies for positioning a device on the market, they must not only understand their own market and its regulatory requirements but also
- keep a close eye on the activities of the competition,
- be familiar with similar and equivalent devices,
- and be informed about alternative devices and procedures.
They must be familiar with their own and third-party devices in order to
- determine state of the art,
- to identify risks,
- be able to compare the benefits of these devices.
2.4 Strong communication and negotiation capabilities
Good negotiation skills and assertiveness are helpful. Clinical affairs managers often act as intermediaries between different stakeholders (such as regulatory authorities, clinical research partners, and internal teams) and must effectively represent their company’s interests.
2.5 Very good English skills
As the medical device sector is often international, very good English skills are essential to communicate effectively with partners, authorities, and colleagues worldwide.
2.6 Organizational skills
Clinical affairs managers must lead and organize themselves and their teams. They must not get lost in the flood of information. Instead, they must be able to set priorities for themselves and others and actively drive forward the often complex projects with many stakeholders.
An independent working style is a minimum requirement for this.
2.7 Capability to act economically
The costs of clinical investigations are considerable. The duration of clinical investigations is also decisive for the economic success of medical device manufacturers. Clinical affairs managers therefore need a healthy pragmatism and knowledge of resources.
Otherwise, management will not value them as a valuable partner in device and business strategy decisions.
3. Regulatory requirements for clinical affairs managers
Laws and standards place requirements on clinical affairs managers’ competencies, activities, and work results. Because other articles already describe the requirements for activities and work results, this article focuses on the regulatory requirements for competencies and qualifications.
3.1 Requirements of the MEDDEV 2.7/1 rev.4
Clinical affairs managers who prepare clinical evaluations are called “evaluators.” MEDDEV 2.7/1 sets requirements for their qualifications. This way, the guideline aims to ensure that a competent person or team performs the evaluation.
Manufacturers must be able to justify the selection of evaluators by referring to their qualifications and documented experience.
3.1.1 General requirements
In general, evaluators must have knowledge in the following fields:
- Research methodology: this includes clinical trial design and biostatistics.
- Information management: Training in a scientific field or library science and experience with relevant databases such as Embase and MEDLINE is required.
- Regulatory requirements: Evaluators must be familiar with legal requirements.
- Medical writing: Postgraduate experience in a relevant scientific field or medicine and training and experience in medical writing, systematic review, and clinical data evaluation are required.
3.1.2 Product-specific requirements
For the specific device being evaluated, evaluators should also have the following:
- Knowledge of the device technology and its application
- Diagnosis and management of the conditions the device is intended to diagnose or treat, including knowledge of medical alternatives, treatment standards, and technologies.
3.1.3 Formal requirements for training and experience
Evaluators should have at least a university degree in the relevant field plus 5 years of documented professional experience or 10 years of documented professional experience if a degree is not required.
In certain cases, the required expertise of the evaluators may differ. This must be documented and justified accordingly.
3.2 Requirements of the EN ISO 14155-2021
Another task of clinical affairs managers is the preparation of clinical studies or investigations. The qualification requirements of EN ISO 14155-2021 for authors of clinical investigations are stringent and are intended to ensure that the assessment and interpretation of clinical data are carried out by persons who are both competent and experienced.
In general, authors of clinical investigations must …
- have sufficient training and experience in the relevant scientific or medical fields to adequately assess the methodological quality, scientific validity of the information, and its relevance to the clinical evaluation.
- be able to evaluate the contributions of different data systematically sets to clinical evaluation.
- know how to conduct clinical investigations, including planning and statistical analysis.
- be familiar with and comply with the relevant legal requirements, in particular, the determinations of Good Clinical Practice (GCP).
- Publication in a reputable peer-reviewed scientific journal may be considered an indicator of scientific quality; however, this does not replace the evaluators’ need for a thorough assessment.
These requirements the utmost care and scientific integrity.
3.3 Interim conclusion
The requirements for the competencies of clinical affairs managers in practice and the regulatory requirements for their competencies are not entirely congruent. For example, laws, standards, and guidelines do not require economic thinking or communication skills. Conversely, regulatory requirements insist on experience, which is measured in years. In practice, the “years of experience” do not always correlate with actual competence.
A medical degree alone does not qualify a person as a specialist in clinical affairs. Authorities and notified bodies regularly expect proof of competence in medical writing, research, and evaluation of clinical data, as well as knowledge of their own device, which newly qualified doctors often do not have.
4. Further education and training
Continuing education is crucial in the dynamic field of medical devices. There are numerous training courses and certificates, including specialized courses in clinical research, regulatory affairs, and quality assurance.
4.1 Further education at universities in Germany
- WWU Weiterbildung gGmbH in Münster
Seminars and further training courses universities offer can strengthen core competencies for clinical affairs managers in the respective disciplines. Specialized topics from master’s degree courses may be taught here in a compact form. - Mibeg Institute of Medicine in Cologne
It provides a wide range of training options that may be of interest to clinical affairs managers, particularly in clinical research and related disciplines. Deepening interdisciplinary knowledge can be of central importance. - Center for Scientific Continuing Education at the University of Mainz
Local continuing education programs focusing on relevant areas such as genetic engineering and radiation protection broaden the understanding of specific product development and inspection aspects.
4.2 Industry-specific training
4.2.1 Offers from the Johner Institute for medical device manufacturers
The Johner Institute offers several training courses for clinical affairs managers:
- Our seminars provide you with first-hand knowledge. Tried and tested knowledge that you can implement directly in your company and that will simplify your daily work.
- Our e-learning platform teaches (future) clinical affairs managers how to write clinical assessments, among other things. They will find all the “official” specialist knowledge on related areas, such as risk management, that they also need to have. They also receive all the necessary templates (e.g., CEP, CER, SOP) for clinical evaluation, literature search protocol, etc.
4.2.2 Further industry-specific offers
- MACS® Academy of Miltenyi Biotec: Offers training focused on technology and application fields, which is important for product knowledge and technological capabilities.
- PME – Institute for Education in Pharmaceutical Medicine: Complements clinical expertise with in-depth knowledge of pharmaceutical medicine, which can be essential for a holistic understanding of the product life cycle.
- AdvoGenConsult – AGCT, Bender & Kauch GbR: Offers highly specialized courses, for example for project managers in genetic engineering, which can be useful for certain areas of product development and safety.
5. Careers and earnings potential
5.1 Employers
Important employers for clinical affairs managers are
- medical device manufacturers
- manufacturers of other devices, e.g., IVD medical devices, companion diagnostics, pharmaceuticals
- notified bodies and authorities
- clinical research organizations
- consulting firms such as the Johner Institute
- associations, e.g., manufacturers’ associations
5.2 Career paths
Clinical affairs managers can develop their careers in various directions. One possible career path consists of the following steps:
- Junior Clinical Affairs Manager
- Senior Clinical Affairs Manager (Team Lead)
- Vice President of Clinical Affairs
- Senior Vice President Clinical and Regulatory Affairs
- Chief Medical Officer
Other careers include tasks in marketing and sales, in-house research, or moving from a manufacturer to a consulting firm or your own start-up.
5.3 Earnings
The salary range for clinical affairs managers in Germany is broad, ranging from EUR 40,000 for a career starter to several EUR 100,000 for a chief medical officer.
Factors that determine earnings are
- education
- age
- experience
- position in the company
- company size
- type of company (e.g., public service, medical device manufacturer, pharmaceuticals)
- location
Sources such as Stepstone and Glassdoor show salary ranges between €57,300 and €77,400 per year.
6. Frequent misconceptions
Some people have misconceptions about the role of clinical affairs managers. To avoid these misconceptions, it is important to take a holistic view of their competencies and understand their role across the entire product lifecycle.
Misconception 1: An exclusively medical background is sufficient
A wide range of capabilities are required, including regulatory knowledge and project management skills. Therefore, interdisciplinary training and industry-specific experience are essential.
Misconception 2: The clinical evaluation is only relevant before market launch
Clinical evaluation is a continuous process that must be continued throughout the product life cycle.
With the new Medical Device Regulation (MDR), manufacturers must demonstrate the safety and performance of their devices even after market launch through post-market clinical follow-up (PMCF) activities.
Misconception 3: Only data from the clinical affairs department is relevant for clinical evaluation
Manufacturers must also consider data from other areas, such as risk management and product development, during the clinical evaluation.
Collaboration between the authors of the clinical evaluation, risk management, and clinical affairs is essential.
Misconception 4: Clinical affairs managers only have tasks in the area of literature research and study planning
In addition to these core tasks, clinical affairs managers also fulfill hybrid tasks in the areas of medical writing and clinical project management.
They must create and monitor all technical documentation for medical devices.
7. Summary and conclusion
The combination of scientific expertise, market knowledge, communication capabilities, and strategic thinking positions clinical affairs managers as key figures in the medical device industry, on whose work the safety and effectiveness of devices brought to market ultimately depends.
With the ever-changing regulatory landscape and technological advances in medical technology, there are opportunities for advancement.
This position offers a rewarding and dynamic work environment for those seeking a career at the interface of medicine, science, and regulation.
Many clinical affairs managers work at the Johner Institute. The Institute is regularly looking for new colleagues.
