For the expansion of their team, a leading medical device company is seeking a Clinical Research Specialist. This individual will play a pivotal role in supporting one or several clinical trials within the Clinical R&D Department, while also cultivating robust and collaborative relationships with colleagues throughout the organization.
Main activities are:
Serves as a Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones;
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;
May act as Clinical Safety Coordinator (See ANNEX I – Clinical Safety Coordinator Duties and Responsibilities);
Mentors team members;
May perform other duties assigned as needed;
Is responsible for communicating business related issues or opportunities to next management level.
Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
Should develop a strong understanding of the pipeline, product portfolio and business needs;
Generally manages work with supervision, dependent on project complexity.
Independent decision-making for simple and more advanced situations but requires guidance for complex situations.
Qualifications
Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
Minimum of 5 years of experience in a similar position within Clinical Operations
Previous experience in clinical research or equivalent is required.
Relevant industry certifications preferred (i.e., CCRA, GCP, ISO 14155, MDR, MEDDEV,…).
Clinical/medical background is a plus.
Medical device experience is highly preferred.
Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;
Proven track record in supporting delivery of clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
Good presentation and technical writing skills;
Good written and oral English communication skills;
What we offer:
We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers , eco vouchers, mobile phone (data included)
We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, ...)
Side activities will be organised regularly, to achieve a close collaboration within our team
We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
We contribute to a number of charities & support the research and / or the patients in our industry.