PlusOne

Clinical Trial Associate - MedTech - Brabant Wallon

Company

Our client is a medical device company focused on the development of innovative therapeutic solutions for the treatment of headache disorders.

They are developing a novel simple solution, discreet, a user-friendly device for a better health, comfort, and quality of life of patients. They strongly believe that people suffering from headaches should benefit from the latest neuromodulation therapies, which are safe alternatives to drugs.

Job Purpose

Are you interested in helping to shape a young, innovative company? Would you like to participate in the development of minimally invasive treatments for headaches? The company is developing technologies focused on providing patients with better health, comfort, and quality of life. They strongly believe people suffering from headaches should benefit from the latest therapies that improve outcomes. To reinforce their clinical team, they are looking for a Clinical Trial Associate.

Role

The Clinical Trial Associate (CTA) is responsible for providing clinical trial administrative support to ensure compliance with company Standard Operating Procedures (SOPs). The candidate will have responsibility for undertaking many aspects of the delivery of the Company’s clinical trial program under the direction and guidance of the Head of Clinical Affairs (HCA) and Clinical Project Managers (CPMs).

Your responsibilities:

  • Work according to the highest standards of quality defined by the SOPs
  • Supports creation of clinical trial documents from draft through final documents and amendments
  • Track and file country/centre-specific essential documents in project administrative binders and project folders.
  • Create and maintain all trial files, including the trial master file, and oversight of site files
  • Update internal project administrative databases.
  • Initiate, develop and maintain trial electronic data capture systems and remotely monitor trial endpoints.
  • Prepare site investigator files and materials for initiation visits. - Prepare / follow up on centre activation documents.
  • Organize and track the shipment of study-related documents. - Support and track shipment of project-related equipment/data.
  • Archive study documentation and correspondence.
  • Manage study administrative activities, maintain study documentation and collect and review regulatory documentation.
  • Support regulatory submissions
  • Tracks and reports the progress of clinical trials, including timelines and deliverables
  • Support the organisation of necessary meetings, e.g. study team meetings, investigator meetings, monitors’ workshops, and CRO training
  • Attend project-related meetings and write minutes - Support maintenance of clinical documents, memberships/licensure (MedDRA) and online research databases (clinicaltrials.gov, EUDRAct) in support of FDA and European regulatory requirements.
  • Contributes to the development of in-house operations, SOPs, guidelines, systems, best practices, and lessons learned exercises
  • Develops and maintains key relationships, both internal and external to the project - Supports GCP compliance and quality initiatives
  • Identification, communication, issue resolution and adherence to SOPs and guidelines - Travel domestically and internationally as required
  • Other duties as assigned by management

Profile

  • Background in a scientific or clinically relevant discipline. Your experience and core competencies:
  • At least two years of experience in project coordination/management, including international clinical trials experience, mainly in Medical devices, and experience with premarket clinical studies in Europe.
  • Preference for experience in clinical neurology
  • Knowledgeable of Phase I-III clinical trials - Experience with ISO 14155 clinical investigation of medical devices for human subjects
  • Good clinical practice
  • Experience setting up and managing project management software, e.g. Clinical Trial Management Systems (CTMS)
  • Proficiency with Microsoft Office suite, e.g. MS Project, Word, Excel, PowerPoint. - Strong communication skills, i.e. articulate expectations via verbal and written communications at varying professional levels, especially in the medical profession.
  • Ability to work with a sense of urgency, prioritise work, and meet objectives/ deadlines with solid organisational capability.
  • Ability to adapt to a fast-paced, changing work environment.
  • Strong analytical, organisational and project management skills
  • Ability to work independently and within a team structure
  • Strong understanding of the healthcare environment, including key external stakeholders

Offer

Our client offers a dynamic and ever evolving start-up atmosphere and team. You would have the chance to get involved in the company evolution and in the full chain of development, from specifications to clinical investigations and market and, ultimately, help improve people’s life.

Our client offers a full-time open-ended contract and good salary package and flexible advantages.

How to apply?

If you are interested in this challenging opportunity, please address your application (CV and short motivation text, both in English) to our recruitment partner, Plus One:

Mr Thomas Léonard, by email on tleonard@plusonesearch.be or apply directly on www.plusonesearch.be

Only selected candidates will be contacted.

Publication date

10.11.2022

Contact person

Leonard

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