Senior Clinical Research Specialist

📅 Start: nach Absprache | ⏳ Dauer: nach Absprache | 🕐 Auslastung: nach Absprache | 📍 Einsatzort: Diegem, Belgium

Location Diegem Hours/week

Tasks

• Serves as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for Johnson&Johnson MedTech Electrophysiology;

• Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;

• May serve as the primary contact for clinical trial sites (e.g. site management);

• Contributes towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,….);

• Supports applicable trial registration from study initiation through posting of results and support publications as needed;

• Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials;

• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel;

• Interfaces, collaborates and oversees Clinical Research Associates (CRAs);

• Oversees and supports the development and execution of Investigator agreements and trial payments;

• Is responsible for clinical data review to prepare data for statistical analyses and publications;

• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;

• May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;

Requirements

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

• BS with at least

• 4 years

• , MS with at least 3 years, PhD with at least 2 years of relevant experience preferred.

• Strong experience in the development of

• clinical trial documents

• (e.g. study protocol, informed consents,

• Previous experience in clinical research or equivalent is required.

• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).

• Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;

• Clinical/medical background is a plus.

• Medical device experience is highly preferred.

Additional information

This contract will run for a

1 year duration.

This role has a large amount of travel (around 80% travel depending on project needs) across EU countries.

Base will be in Diegem.

40 hours per week (100% is required)

you are welcome here

J&J

is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

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