Clinical Study Specialist

il y a 4 semaines

Diegem, Belgique ClinChoice Temps plein

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds.

ClinChoice, is searching for a Clinical Study Specialist to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work in a hybrid model in Diegem, 1.0 FTE permanent contract.

**Scope of the role**:
This individual will provide support to the clinical study staff within Clinical R&D, as well as fostering strong, productive relationships with colleagues within the Clinical R&D organization.

Responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects. In addition, administratively support clinical study staff as required. Supports project managers within the assigned clinical studies.

**Main Job Tasks and Responsibilities**:

- Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.
- Creation/distribution of regulatory binders & the wet-ink signed documents binder.
- Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File). Respond to problems and assists in implementing corrective and preventive actions.
- Assist in providing internal communication of important clinical data and events.
- Support ongoing use of (one)CTMS by maintaining and tracking relevant activities.
- Provide safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).
- May be asked to provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs.
- May be asked to assist with Device tracking and ordering if required and if applicable.
- Assistance with logistics for Investigator meetings/expert panel meetings.
- Assistance with distribution of newsletter (create mailing list from (one)CTMS and routing for internal approval).
- Participates in process improvement activities related to (one) CTMS/vTMF within the department.
- May provide other administrative support for clinical study or departmental activities as needed and assigned by supervisor or study leaders.

**Education and Experience**:

- Minimum of a Bachelor's Degree is required.
- Previous clinical research experience a plus.
- Requires previous administrative support experience or equivalent for at least 1 year.
- Clinical/medical background a plus.
- Requires experience and knowledge working with computer systems (Microsoft office - Excel, Word and Power Point).

**Specific Role Requirements and Skills**:

- Tracking.
- Written and verbal communications.
- Attention to details.
- Organizational skills.
- Fluent in English and Dutch (spoken and written).

**Our Benefits**:

- Competitive Salary.
- Group and hospitalisation insurance.
- Electronic meal vouchers.
- Internet reimbursement.
- Excellent work-life balance.
- Dedicated Line Manager.
- Full performance and development process with end of year reviews.
- Career opportunities within in ClinChoice, locally and globally.
- Employee satisfaction survey - your feedback is important for continuous improvement.

**_The Application Process_**:
**Who will you be working for?**

**_ About ClinChoice_**:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

**_ Our Company Ethos_**:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate

  • Clinical Study Specialist

    il y a 6 jours

    Diegem, Flandre, Belgique ClinChoice Temps plein

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds.ClinChoice, is searching for a Clinical Study Specialist to join one of our partner companies, a large pharmaceutical company leader in the field of...

  • Clinical Study Administrator

    il y a 3 semaines

    Diegem, Flandre, Belgique Randstad Temps plein

    You will provide support to the clinical study staff within Clinical R&D, as well as fostering strong, productive relationships with colleagues within the Clinical R&D organization.Responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects. In addition, administratively support...

  • Clinical Study Administrator

    Il y a 2 mois

    Diegem, Flandre, Belgique Randstad Temps plein

    You will provide support to the clinical study staff within Clinical R&D, as well as fostering strong, productive relationships with colleagues within the Clinical R&D organization.Responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects. In addition, administratively support...

  • Clinical Study Administrator

    Il y a 2 mois

    Diegem, Belgique Randstad Travail à distance Freelance Temps plein

    You will provide support to the clinical study staff within Clinical R&D, as well as fostering strong, productive relationships with colleagues within the Clinical R&D organization.Responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects. In addition, administratively support...

  • Senior Clinical Research Specialist

    il y a 6 jours

    Diegem, Flandre, Belgique Pauwels Consulting Temps plein

    Job description: For one of our major clients within life sciences region Diegem, we are looking for a Senior Clinical Research Specialist.As a Senior Clinical Research Specialist, you will be responsible for: Serves as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring...

  • Clinical Study Assistant Fr/en or Nl/en

    il y a 6 jours

    Diegem, Flandre, Belgique Oxford Global Resources Temps plein

    (Junior) Clinical Study Assistant FR/EN or NL/EN: Location:Diegem, Belgium Contact:Amandine Planche Job type:Permanent Contact phone: Industry:Pharmaceutical, Life Sciences, Clinical ResearchThe Clinical Study Assistant will provide support to the clinical study staff within Clinical R&D, as well as fostering strong, productive relationships with colleagues...

  • (Junior) Clinical Study Assistant Fr/en or Nl/en

    il y a 3 semaines

    Diegem, Belgique Oxford Global Resources Temps plein

    **(Junior) Clinical Study Assistant FR/EN or NL/EN**: - Location: Diegem, Belgium - Contact: Amandine Planche - Job type: Permanent - Contact phone: +32 10 68 53 34 - Industry: Pharmaceutical, Life Sciences, Clinical Research The Clinical Study Assistant will provide support to the clinical study staff within Clinical R&D, as well as fostering strong,...

  • Senior Specialist Clinical Quality Assurance

    il y a 3 semaines

    Diegem, Belgique Boston Scientific Corporation Temps plein

    **Senior Specialist Clinical Quality Assurance**: - Remote Eligible: Remote Global- Onsite Location(s): Diegem, BE**Additional Locations**: Netherlands-Kerkrade; Germany-Düsseldorf **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s...

  • Clinical Study Administrator

    il y a 3 semaines

    Diegem, Flandre, Belgique Randstad Temps plein

    Je biedt ondersteuning aan het klinische onderzoekspersoneel binnen Clinical R&D en onderhoudt sterke, productieve relaties met collega's binnen de Clinical R&D-organisatie.Verantwoordelijk voor het verwerken, volgen en archiveren van onderzoeksdocumenten en het beheer van het Trial Master File binnen de klinische projecten. Daarnaast administratief...

  • Clinical Study Administrator

    Il y a 2 mois

    Diegem, Flandre, Belgique Randstad Temps plein

    Je biedt ondersteuning aan het klinische onderzoekspersoneel binnen Clinical R&D en onderhoudt sterke, productieve relaties met collega's binnen de Clinical R&D-organisatie.Verantwoordelijk voor het verwerken, volgen en archiveren van onderzoeksdocumenten en het beheer van het Trial Master File binnen de klinische projecten. Daarnaast administratief...

  • Clinical Study Administrator

    Il y a 2 mois

    Diegem, Belgique Randstad Travail à distance Freelance Temps plein

    Je biedt ondersteuning aan het klinische onderzoekspersoneel binnen Clinical R&D en onderhoudt sterke, productieve relaties met collega's binnen de Clinical R&D-organisatie.Verantwoordelijk voor het verwerken, volgen en archiveren van onderzoeksdocumenten en het beheer van het Trial Master File binnen de klinische projecten. Daarnaast administratief...

  • Clinical Support Specialist

    il y a 2 semaines

    Diegem, Belgique Johnson & Johnson Temps plein

    ‘Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a...

  • Sr Clinical Project Manager

    il y a 3 semaines

    Diegem, Belgique Syneos Health Clinical Temps plein

    **Description** **Project Manager II** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of. As a part of the Syneos Health team,...

  • Clinical Specialist

    il y a 6 jours

    Diegem, Flandre, Belgique Solventum Temps plein

    Job Description:3M is establishing two industry-leading companies, creating value through the spin-off of its Health Care business, while 3M will continue to be a global material science leader, focusing our innovation to win in favorable global megatrends and attractive end markets.This new Health Care Company will be a leading global diversified health...

  • Clinical Research Specialist

    il y a 2 semaines

    Diegem, Belgique Select Projects Temps plein

    Momenteel zijn we aan het uitkijken naar een **Clinical Research Specialist **voor een farmaceutische klant in Diegem die verantwoordelijk is voor de ondersteuning van één of meerdere klinische studies binnen de afdeling. Als **Clinical Research Specialist **heb je volgende verantwoordelijkheden: - Toezien op de vastgestelde tijdschema's en procedures -...

  • Clinical Research Specialist

    il y a 6 jours

    Diegem, Flandre, Belgique Select Projects Temps plein

    Momenteel zijn we aan het uitkijken naar een**Clinical Research Specialist **voor een farmaceutische klant in Diegem die verantwoordelijk is voor de ondersteuning van één of meerdere klinische studies binnen de afdeling.Als**Clinical Research Specialist **heb je volgende verantwoordelijkheden:- Toezien op de vastgestelde tijdschema's en procedures- Je...

  • Clinical Contracts Associate

    il y a 6 jours

    Diegem, Flandre, Belgique Oxford Global Resources Temps plein

    Location:Diegem, Belgium Contact:Amandine Planche Job type:Permanent Contact phone: Industry:Pharmaceutical, Life Sciences, Medical Device & Diagnostics, Clinical ResearchFor one of our clients, a medical device company, we are looking for a Clinical Contract Associate to come on board and join their Clinical Contract EMEA team.As Clinical Contracts...

  • Clinical Contracts Associate

    Il y a 2 mois

    Diegem, Belgique Oxford Global Resources Temps plein

    Location: Diegem, Belgium - Contact: Amandine Planche - Job type: Permanent - Contact phone: +32 10 68 53 34 - Industry: Pharmaceutical, Life Sciences, Medical Device & Diagnostics, Clinical Research For one of our clients, a medical device company, we are looking for a Clinical Contract Associate to come on board and join their Clinical Contract EMEA...

  • Talent Community: Field Clinical Specialist

    il y a 3 semaines

    Diegem, Belgique Boston Scientific Corporation Temps plein

    **Talent Community: Field Clinical Specialist, Electrophysiology (Farapulse)**: - Work mode: Field Based- Onsite Location(s): Diegem, BE**Additional Locations**: Belgium-Diegem **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within...

  • Talent Community: Field Clinical Specialist

    il y a 6 jours

    Diegem, Flandre, Belgique Boston Scientific Corporation Temps plein

    Talent Community:Field Clinical Specialist, Electrophysiology (Farapulse):Work mode: Field BasedOnsite Location(s): Diegem, BEAdditional Locations: Belgium-DiegemDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of...