As a Senior Clinical Research Specialist, you will be responsible for supporting one or more clinical studies within the Clinical R&D department while nurturing strong, productive relationships with colleagues across the organization.You will serve as Senior Clinical Research Specialist within the Clinical R&D department to support and execute company-sponsored clinical trials, ensuring compliance with timelines and research. In addition, you will oversee/perform the feasibility, selection, design, execution and closure of a clinical trial within the assigned countries, in accordance with ICH-GCP, applicable laws and company and you will be the primary point of contact for clinical trial sites.
...senior clinical research specialist.
- posted 5 september 2023
- closes 3 november 2023
key responsibilities
- Contributes to the development of clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports, etc.)
- Supports applicable research registration (e.g., www.clinicaltrials.gov) from study initiation posting results and supporting publications as needed;
- Manages/oversees ordering, tracking and accounting for research equipment and experimental materials
- Interfaces and collaborates with site personnel, IRBs/ECs, contractors/suppliers and company personnel
- Interfaces, collaborates and supervises Clinical Research Associates (CRAs)
- Oversees and supports the development and execution of research agreements and litigation payments
- Is responsible for reviewing clinical data to prepare data for statistical analysis and publications
- May conduct monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or closure 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 assigned projects
- May provide on-site procedural protocol compliance and data collection support to clinical institution trial sites
- Contributes to the execution of assigned clinical projects, through effective partnership with the study core team leading to fulfillment of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs)
- May assist in the development of e-Post-Market Clinical Follow-up (PMCF) plans and PMCF
- May assist in maintaining oversight so that (study) agreements are met timely and properly by coordinating specific documentation and contributing to cross-functional review of associated documents, when relevant
- May act as clinical safety coordinator
- Is responsible for ensuring personal and corporate compliance with all federal, state, local and company regulations, policies and procedures
- Must develop a strong understanding of the pipeline, product portfolio and business needs
qualifications
- Minimum of a bachelor's degree, preferably in Life Science, Physical Science, Nursing, Biomedical Sciences
- Bachelor with minimum 4 years, Master with minimum 3 years, PhD with minimum 2 years relevant experience is preferred.
- Previous clinical research experience or equivalent is required.
- Preferably relevant industry certifications (i.e. CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,...).
- Clinical/medical background is a plus.
- Medical device experience strongly preferred.
- Good understanding of clinical research science and processes, clinical trends and global clinical trial regulations
- Proven track record of supporting the execution of clinical projects within clinical/surgical research on time, within budget and in compliance with SOPs and regulations
- Good presentation and technical writing skills
- Good written and oral English communication skills
- Connect - Develop collaborative relationships with key internal and external stakeholders.
- Recommends and actively participates in departmental process improvement activities.
- Takes responsibility for critical scientific thinking and self development and participates in transparent and constructive conversations.
- Strives to ensure that all results of assigned research are achieved on time, within budget and in accordance with SOPs and regulations.
key benefits
- Gross salary
- Meal vouchers of €7
- Net entertainment expenses of €80
- Hospitalization insurance
- Car + unlimited fuel card or kilometer allowance
- 32 vacation days
- End-of-year bonus
- Pension plan
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bianca dardenne
