For one of our clients in Brussels, we are currently looking for a "Senior Clinical Research Specialist".
Job Description
As a Senior Clinical Research Specialist, you 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.
Responsibilities
- Oversight/execution of 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);
- Contribute towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,….),ensure registration on www.clinicaltrials.gov from study initiation through posting of results and support publications as needed;
- Management/oversight of ordering, tracking, and accountability of investigational products and trial materials;
- Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
- Oversee the development and execution of Investigator agreements and trial payments;
- Responsible for clinical data review to prepare data for statistical analyses and publications;
- If applicable, 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;
- If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center; Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;
- Contribute 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);
- 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;
- Support project/study budget activities as assigned;
- Develop a strong understanding of the pipeline, product portfolio and business needs;
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.
Requirements
- Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
- Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
- Medical device experience highly preferred.
- Good understanding and experience 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 communication skills;
- Connect - Develop collaborative relationships with key internal and external stakeholders.
- Shape - Make recommendations for and actively participate in departmental process improvement activities.
- Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.
- Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.
Benefits
- A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 16585
