CRA II / Senior Clinical Research Associate (French speaking)
Guildford, England, United Kingdom · On-site
Mid level
Company Description Medicine moves forward here. So will you. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studi…
Skills: On-site Monitoring, Clinical Trial Management, French Proficiency, English Proficiency, Regulatory Submissions
Company Description Medicine moves forward here. So will you. Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so …
Company Description Medicine moves forward here. So will you. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studi…
PV Officer- Senior PV Officer, Team Leader (Pharmacovigilance Manager)
Belgrade, Central Serbia, Serbia · On-site
Mid level
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Skills: Pharmacovigilance, Line Management, ICSR Processing, KPI Management, Quality Control
PV Officer- Senior PV Officer, Team Leader (Pharmacovigilance Manager)
Sofia, Sofia-City, Bulgaria · On-site
Mid level
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Skills: Pharmacovigilance, Line Management, ICSR Processing, KPI Management, Quality Control
Senior Pharmacovigilance Officer, Team Lead/ Case Processing Manager- Medical Device experience needed
Warsaw, Masovian Voivodeship, Poland · On-site
Senior
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Skills: ICSR Management, Pharmacovigilance, Medical Device Safety, Line Management, KPI Creation
Senior Pharmacovigilance Officer, Team Lead/ Case Processing Manager- Medical Device experience needed
Zagreb, Croatia · On-site
Senior
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Skills: Pharmacovigilance, ICSR Management, Medical Device Safety, Line Management, Case Processing
Company Description Medicine moves forward here. So will you. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studi…
Company Description Medicine moves forward here. So will you. Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studi…
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Skills: ICSR Management, Pharmacovigilance, Line Management, KPI Creation, Quality Control
Company Description Medicine moves forward here. So will you. Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so …
Company Description Medicine moves forward here. So will you. Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so …
Company Description Medicine moves forward here. So will you. Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so …
Company Description Medicine moves forward here. So will you. Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so …
Sarajevo, Federation of Bosnia and Herzegovina, Bosnia and Herzegovina · On-site
Entry level
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Skills: Signal Detection, Pharmacovigilance, Line Listing Review, Quality Control, Record Keeping
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Skills: Pharmacovigilance, Project Management, ICSR Processing, Aggregate Reports, Literature Screening
Company Description Medicine moves forward here. So will you. Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so …
Company Description Medicine moves forward here. So will you. Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so …
Senior Director / Executive Director Medical Writing
Sarajevo, Federation of Bosnia and Herzegovina, Bosnia and Herzegovina · On-site
Senior+
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Skills: Pharmacovigilance, Medical Writing, People Management, Regulatory Compliance, Aggregate Safety Reports
Senior Director / Executive Director Medical Writing
Belgrade, Central Serbia, Serbia · On-site
Senior+
Company Description Medicine moves forward here. So will you. At PrimeVigilance, patient safety is not one part of the job. It is why we exist. We are a global pharmacovigilance specialist. Our teams help clients navigat…
Skills: Pharmacovigilance, Medical Writing, People Management, Regulatory Compliance, Aggregate Safety Reports
CRA II / Senior Clinical Research Associate (French speaking)
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Full-time
bachelor degree
Posted 15d ago
~40 hrs/week
Responsibilities
Perform on-site and remote monitoring visits including pre-study, initiation, interim, and close-out activities. Ensure investigational sites have adequate qualifications and resources while training site staff and supporting regulatory submissions.
Requirements
Requires a degree in Life Sciences and extensive on-site monitoring experience in phase 2/3 trials, particularly in oncology or rare diseases. Full working proficiency in both English and French is essential, along with the ability to travel.
Full job description
Company Description
Medicine moves forward here. So will you.
Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.
We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.
That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported.
If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.
Job Description
National Travel Required as well as travel to France and Belgium (French-speaking part)
Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study
Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conducting the clinical study throughout the study period.
Trains investigational site staff as necessary
When applicable, supports preparation of regulatory and / or EC submissions
Qualifications
College/University degree in Life Sciences or an equivalent combination of education, training & experience
Extensive on-site monitoring experience in phase 2/3 trials, ideally with experience of complex trials such as oncology / rare dieses
Full working proficiency in English and French
Ability to plan, multitask and work in a dynamic team environment
Communication, collaboration, and problem-solving skills
Ability to travel
Additional Information
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
Quality: we hold ourselves to the standard patients deserve.
Integrity and trust: we do the right thing, especially when it is hard.
Drive and passion: we care about the outcome, because someone is waiting on it.
Agility and responsiveness: we move quickly, because patients cannot wait.
Belonging: everyone is welcome, and every voice counts.
Collaborative partnerships: we go further by going together.
PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative clinical safety and PV services for pharmaceutical, biotechnology and medical device companies. Our leaders have an unrivalled reputation in the sector with a network of SMEs across the world. These include former senior regulators and consultants with expansive industry experience.
Offices: The Surrrey Research Park, 1 Occam Court, Guildford, Surrey GU2 7HJ, GB · Oreškovićeva ul. 6H, Zagreb, 10 020, HR · Đorđa Stanojevića 14, Novi Beograd, 11 070, RS · Herriotstr. 1,, Frankfurt am Main, Frankfurt 60528, DE · Václavské náměstí 2132/47, Flow Building, Prague, Prague 1 110 00, CZ
PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative clinical safety and PV services for pharmaceutical, biotechnology and medical device companies. Our leaders have an unrivalled reputation in the sector with a network of SMEs across the world. These include former senior regulators and consultants with expansive industry experience.
Offices: The Surrrey Research Park, 1 Occam Court, Guildford, Surrey GU2 7HJ, GB · Oreškovićeva ul. 6H, Zagreb, 10 020, HR · Đorđa Stanojevića 14, Novi Beograd, 11 070, RS · Herriotstr. 1,, Frankfurt am Main, Frankfurt 60528, DE · Václavské náměstí 2132/47, Flow Building, Prague, Prague 1 110 00, CZ