Fiona Jones talks to two clinical
research scientists who have exchanged the familiar comforts of their
native countries for unknown challenges abroad, and found it a thoroughly
rewarding experience. Both men initially found it hard to adjust to
the fundamentally distinct approaches to work, but are now convinced that
working abroad has been a positive experience leading to increased independence
and receptivity to alternative working practices.
unity arising from the formation of the European
community is manifest in all areas, including harmonization of GCP, and
the removal of employment barriers across Europe. These factors, combined
with the accepted wisdom that foreign work experience is a desirable
career asset, is facilitating a pan-European movement of clinical research
staff. The facility of traveling between England to France in less than 2
hours by 'Le Shuttle' is resulting in many pharmaceutical companies
in the South East of England conducting clinical studies in France.
However, despite the ease of movement and the increasing standardization
of working practices, inevitable cultural differences remain. These
differences influence the human interactions, not described in SOPs, which
are ultimately responsible for the efficiency and effectiveness of
|This article chronicles
the experiences of a French clinician with the opportunity of working in
England and an English clinical research scientist currently working in
France. Two years later, both men have kindly agreed to share their
experience with us. We look at how they have adapted to the change in
their cultural environment and ask what have they learnt about working in
another European country, and also what advice can they offer to anyone
presented with a similar opportunity.
In 1996, Tony Doyle lived in the industrial West
Midlands and commuted weekly to Weybridge in Surrey where he was employed
as a Research Manager for SmithKline Beecham Consumer Healthcare. Today he
lives in a picturesque village in the heart of rural France and works as a
Chargé d'Etudes en Pharmacocinétique Clinique for a French
pharmaceutical company. In the same year Gilles Knecht swapped his rural
French life, moving from the company's R&D site in France, where he
was a Clinical Research Physician (Project Leader) to become their Medical
Director at the company's Slough office.
What they do
Tony's role within the Clinical Pharmacokinetics
Group includes all areas of phase I clinical study co-ordination, from
protocol design to analyzing and reporting results. Gilles position is at
the other end of the clinical trial process. He has a very broad
responsibility including phase III and IV study management;
pharmacovigilence; medical and regulatory affairs and marketing support.
He also has input in training the medical sales force and validating
Why they moved
The reasons why Tony and Gilles decided to move
are quite different. Tony applied to a job advertisement for a Clinical
Study Manager to be based in Burgundy, France. His reasons for applying
were two-fold. Firstly, from a career perspective, Tony wanted to work in
ethical pharmaceuticals to complement his OTC experience and he thought
that overseas experience would benefit his long-term employability.
However, apart from the career considerations, Tony adds:
'…the idea of moving to France conjured up
pleasant connotations, wine, food and clean air, and the element of
adventure appealed to me. It seemed like a wonderful opportunity for me
and my family to learn another language and to experience another
For Gilles the move was at the request of his
employer who wanted to strengthen their medical group in Slough, in order
to improve the company's position within the UK. The company wanted to
improve links between the UK office and the parent company thereby
reinforcing and strengthening their corporate culture.
Their main difficulty - the language barrier
The main difficulty experienced by both men was
undoubtedly the language.
After what he refers to as a bilingual
interview, 'Bonjour' in French and the remainder in the good
English of his French hosts, Tony was successful in securing a permanent
job offer. He then spent the next 3 months listening to tapes in the car
and attending local evening classes. On his first day at work he quickly
realised that he had overestimated his 'French at the Wheel' linguistic
'My French language classes and tapes had me
perfectly prepared for ordering a meal at the company restaurant. The rest
of the time I was completely lost. I couldn't understand a single word. It
was very disorientating.'
His boss decided to ban the use of spoken
English at work for the first year to enable him to get a grasp of the
language. On reflection he feels that this was
'A smart move but a painful one.'
Scientific staff in the company all have English
language training and are keen to practice and improve whenever the
opportunity presents itself. Tony feels that given the chance at the early
stages to speak English it would have been very difficult to make the
transition to French. With the language difficulty, Tony describes his
first 6 months as:
'……..working in a fog : I couldn't perceive
more than an outline of what was happening around me, let alone discern
the important nuances that one quickly establishes in English - nature of
relationships, the ability to read between the lines etc. The fog
gradually lifted as I learnt the sound of the language, yet speaking was
still an effort and I noticed that I wasn't as effective as I was in
England, especially in management and co-ordination activities.'
Thankfully for Tony most working documents;
protocols, and study reports were in English. His attempts at mastering
the language have also led to some embarrassing moments. When arranging an
afternoon meeting with two female technicians attempts to book 'une
chambre' (bedroom) instead of 'une salle' (in this case a conference
room) were met with raised eyebrows.
Gilles had spent many years studying English and
had frequently traveled between France and England attending meeting and
conferences in English yet still the language barrier was his main
obstacle. He found it extremely tiring working in English all day and
found that his powers of concentration waned after a couple of hours. He
felt frustrated at not being able to express his feelings, wanting to be
more precise and accurate when giving advice or instruction.
'After a while I found that so many things in
a language are irrelevant - there is always a lot going on around the main
conversation. I concentrated on determining the real issues and, when
necessary, asked people to repeat the key points. I tried to make it a
positive thing. At the end of a discussion I summarized and repeated back
what I thought I had understood. This took a little time but it avoided
making costly mistakes.'
Tony first impressions of working in France were
how over-worked and stressed everyone was. He found the French extremely
thorough with regard to their work and that they constantly checked and
re-check everything. Any new thoughts or ideas then result in changes and
more checking and double-checking. It appeared the French have difficulty
saying no to making improvements, even if a piece of work is almost
completed, they are quite willing and indeed expect to start all over
again, if there is a new piece of data or idea to be incorporated.
Obviously this makes formal project planning difficult, if not impossible.
The French tend to 'backward plan' - if a deadline is set staff are
prepared to work long hours to make it happen.
'I have had to adapt some of my working
techniques, especially refining my time-management to offset the stress of
a lengthy and unpredictable workload. I feel that now I have a more
serious approach to the detail of the work and I realize it is not
possible to check your work too much. It is the conduct of the study and
not the deadline that is important.'
This thoroughness also applies to study audits.
English study centers that have been audited by Tony's French colleagues
have commented to him that they have never been audited in such detail.
In addition to being serious about their work
the French are also serious about their holidays. French holidays are
traditionally taken between the 14th July and the beginning of
September (la rentrée) for at least three weeks and many
businesses close down entirely for the month of August. In May there are
up to 4 public holidays and where the holiday falls on a Tuesday or
Thursday the day before or after are often also declared as holidays (faire
le pont). This cultural difference must be taken into account when
conducting clinical studies in France. The recruitment of volunteers or
patients especially during the month August is virtually impossible and it
may also be more difficult to find CROs that fully operative during this
period. The month of May often brings logistical problems in arranging
shipments of supplies and a careful record of public holidays (jour
feriés) and any corresponding 'bridge days' (jour pont) must
Gilles was surprised at how totally different
the French and English are in their approach to work. He found the English
to be totally 'monotasked'.
'People want to work on one thing at a time
and finish it before starting the next. They don't like to be disturbed
when they are concentrating on something. This isn't how I am, I don't
think it is how the French are - but it's been good for me. I think it's a
more professional approach and I have tried to adapt a little.'
He finds that the English like to work to a
strict framework. They like a set of rules and they like to apply them.
Gilles feels that the whole concept of GCP with guidelines and regulations
is compatible to the English way of working.
'Before doing anything I am asked: "Where
is it written ?" "Where is it published ?" "Show me
the guidelines !" It is a good way to be when working in clinical
research and very professional. I think the French are more creative and
like to be freer to work without the restrictions of a written framework.'
One of the concepts that Gilles has had to adapt
to is the 'gentleman's agreement'.
'When there are no formal rules or laws, the
English are able to create an unwritten and unspoken code of working. This
does not exist in France and it is very strange to me. It occurs not only
between friends and colleagues but through all areas of business including
the Government. One example is the PPRS (pharmaceutical pricing regulation
scheme). This kind of arrangement would be absolutely unthinkable in
France ! There are many things that are not regulated in England but yet
everyone seems to know the unwritten laws and how to apply them. These
practices are very difficult for a French person to understand.'
Tony has found that there is a more hierarchical
system operating in France with regard to staff structure and working
'The differences that used to operate in England
in the 50's and 60's between blue and white colour workers are very
evident in France today. There is less contact between management and
non-management and different rules apply for their working hours and
conditions. It is also more difficult for non-cadre to progress within
Gilles has also noticed this difference.
'In England staff at all levels are willing to
speak out to senior management, to explain that there is a problem with a
study or that they are unhappy about their salary or working conditions.
It may not be what you want to hear but in the long term it's a good
thing. I think that French employees are much more reserved and diffident
Gilles feels he was very lucky being able to
move from France to England while remaining working for the same company.
He feels it was a great support being able to remain in contact with his
former colleagues and also having the continuity of company culture. He
was also lucky in that his company had previously expatriated four other
colleagues from France to England so he was able to share a joke in French
and learn from others' experiences.
'I think it would be more difficult if you
change countries and company at the same time.'
Tony is in agreement.
'In addition to the changes in your living
conditions, you are an unknown to the company. You have to prove yourself
and that’s difficult when you don't speak the same language.'
Clinical Trial Conduct
The ICH GCP guidelines are not intended to
impose stringent requirements but exist to provide a framework within
which to operate. Within the guidelines member countries can adapt and
impose their own standards. As a result several differences remain between
France and England when conducting clinical studies. For example, the CTX
(Clinical Trial Exemption) system does not operate in France. Gilles had
experience of CTX's before moving to England and is quite comfortable with
'Although it takes a little longer, the CTX
system is useful as by formalizing the application you prepare a detailed
document which is useful later on.'
However, when asked about the system of 'Ethics
Committees in England', Gilles was emphatic.
'In France we have a Central Ethics Committee,
no matter how many study sites there are for a study you only have to
submit to the central committee and to gain approval. The system is simple
and effective. In the UK when we conduct a multi-centre study in less than
5 centers it is necessary to submit the protocol and to gain approval from
each of the centers. When there are 5 or more centers we must first submit
to the relevant MREC (multicentre research ethics committee) and then to
each of the LREC's (Local Research Ethics Commitees) involved in the
study. The system is too complicated and can take too long. Another
problem arises if you receive approval from the MREC but get a rejection
from one of the LREC - the rule in this situation is not clear.'
Gilles has found that there are many benefits in
conducting clinical research in the British NHS.
'Employment laws mean that it is easier in the
UK to pay a hospital department to recruit a Clinical Research Fellow to
conduct a study. This system works very well, it means you have a
dedicated specialist on site. This makes it easier to manage a study and
also aids the recruitment of patients.'
Tony referred to the 'thoroughness of the
French' and the trait is found in aspects of their clinical study
'For phase I studies in France the details of
all participating volunteers are kept in a centralized file. This
information includes the number of studies a volunteer has participated in
and the amount of money earned, which is limited to 25,000FF per year. The
aim of this system is to protect the volunteer and to ensure that a
correct washout period is maintained between studies and also to prevent
participation in two studies at the same time. It's an effective system
that seems to work well.'
Some clinical research professionals' feel that
there is more red-tape to be negotiated before conducting phase I clinical
studies in France. Tony believes that at the moment this is not true.
'The main regulatory hurdle is the 'Déclaration
d'Intention' which must be submitted to the French ministry after Ethics
Committee approval has been received. It is not necessary to wait for a
reply before commencing the study and the submission of the document is
easily handled. However, there is talk of this procedure changing so that
a response to 'la declaration' will be required to authorize commencement
of the study. Fears are that the culture within the ministry are such that
staff will find problems in applications and that such a system will
become a real burden. Certainly CROs performing phase I studies see this
as a real threat to their activities.'
Despite the insistence on following procedures,
maintaining management-non-management differences and working extremely
hard, the French take a much more relaxed approach when it comes to their
expectations of working conditions. The large office suite with leather
chair and mahogany desk are not a common site in France for even the
highest level of management. Company cars are also strictly reserved for
those with a definite need. However when it comes to the social and
medical conditions provided by the government both men whole-heartedly
agree that conditions in France are superior.
Would they do it again
When asked would they do it again both men are
unanimous. Tony believes it was the best move he has made both in terms of
his career and for his family. For Gilles the answer is also a definite
'YES !'. Gilles believes that working abroad, away from the comfort of his
usual environment, has made him more independent and open to new ideas and
different ways of working.
'There are of course times when it is very
difficult. It is impossible to explain the disruption to your family life.
Overnight everything changes and you find yourself a foreigner in a
strange land. We left our home, our friends and family and my wife Carol
also left her job as a psychiatrist. She had to make all the effort to
integrate our family into England but without any of the immediate
benefits. Luckily for me Carol was incredibly supportive. In fact through
her great efforts, she now speaks English very well and has obtained work
at a private practice treating French people living in London. I am very
proud of her.'
Tony understands this sentiment.
'When you are working, you are immediately
surrounded by people and you have a role to fulfill. It is difficult for
the rest of your family they have to give up a lot and the rewards are not
as immediate. I was lucky there were individuals within the organization
who were very understanding and where able to help my wife obtain work.
That made a big difference in making our move a success. If a foreign move
is to be successful the whole family has to work hard at it. Companies
must realize that they are relocating a family not just one employee. If
they want a good return for their investment, it is essential for them to
ensure that the employee's family is happy.'
Tony's advice for anyone considering a move from
England to France is:
'Don't be surprised by anything and don't expect
it to be easy ! Read everything you about living and working in France,
speak French to anyone who will listen to you and be prepared to work very
hard. American management writers advise us to develop by stepping out of
our 'comfort zone' and this is one way to step right out of it ! Keeping a
sense of humor and a positive attitude greatly helps a successful
'I can only speak of London, but if you get the
opportunity take it ! London is a fantastic place to be right now and
there are a lot of opportunities in the area of clinical research.'