Senior Clinical Research Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Diegem, Flemish Brabant, Belgium

Job Description:

Job Description

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Senior Clinical Research Specialist to be based in Diegem, Belgium.

Purpose:

Under general direction, this Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

TASKS AND REPSONSIBILITIES :

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• 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 (e.g. www.clinicaltrials.gov) 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;

• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;

• Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;

Contributes to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);

• May assist with the development of e Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals; May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant;

• Supports project/study budget activities;

• Mentors team members;

• Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholde