Senior Clinical Research Specialist
Il y a 2 mois
**Job description**:
- For one of our major clients within life sciences region Diegem, we are looking for a Senior Clinical Research Specialist. As a Senior Clinical Research Specialist, you will be responsible for:
- 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;
- 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,.);
- 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.
**Benefits**:
- Uitdagende projecten in lijn met jouw interesses en talenten
- Persoonlijke opvolging en open communicatie zowel voor als na indiensttreding
- Mogelijkheid tot het volgen van extra opleidingen
- Inspirerende netwerkevents en legendarische afterwork drinks
- Sterk netwerk van toonaangevende klanten
- Expertise binnen IT, Engineering en Life Sciences
- Een vliegende start voor elke junior, verdere groei en kennisdeling voor onze seniors
- Challenging projects based on your interests and skills
- Personal follow-up and clear, transparent communication both before and after commencement of employment
- Possibility to follow extra training
- Inspiring network events and legendary after work drinks
- Strong network of industry leading clients
- Expertise within IT, Engineering and Life Sciences
- A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
**Have you got what it takes?**:
- For this position, you possess:
- Minimum of a Bachelors 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.
- 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,).
- Clinical/medical background is a plus.
- Medical device e
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