You have a solid experience within clinical trials, able to work in an independent manner, and you are looking for a broad, varied job within a dynamic medical devices company ? Then check out this opportunity. Our medical devices client is looking out to reinforce their clinical team with a motivated and enthusiastic Senior Clinical Research Specialist. Triggered ? Don't hesitate and apply today !
Job Description
The 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.
Responsibilities
- Serve 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
- 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 managing 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;
- If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center;
- 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;
- Assist in tracking assigned project budgets;
- 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;
- Performs other duties assigned as needed;
- Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple situations but required guidance for complex situations.
Requirements
- Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
- BS with at least 4 years, MS with at least 3 year, PhD with at least 2 years of relevant experience preferred.
- Previous experience in clinical research or equivalent is desired.
- Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
- Clinical/medical background 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 clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;
- Good presentation and technical writing skills;
- Good written and oral communication skills in English.
- Develop collaborative relationships with key internal and external stakeholders.
- Actively participate in departmental process improvement activities.
- Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.
- Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.
- Existing right to work in Europe required
Benefits
- A balanced salary package based on your capabilities and experience, including extra legal benefits
Vacancy number: 18730
