Senior Clinical Research Specialist
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.
- Serve as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of 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 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
- Perform other duties assigned as needed
Masters or equivalent required. Preferably in Life Science, Nursing or Biological Science.
- 5 years of experience in the set-up and management of all operational aspects of clinical trials (in academia, industry, or CRO)
- Experience working well with cross-functional teams is required.
- In-depth knowledge of methodologies, regulations and procedures related to clinical trials
- Possess strong analytical skills and highly organized project management abilities, keeping an eye on both detail, while maintaining a broad overview
- Ability to work effectively in multicultural teams and across organizational boundaries, respecting differences between people from a variety of linguistic and cultural backgrounds
- Native or native-like written and spoken English and Dutch
- A high level of integrity and sense of responsibility and professionalism
- An attractive salary in line with your experience and skills.
- Fringe benefits including a company car, medical insurance, pension plan and a care plan.
- A supporting environment.
- Respect for the life-work balance.
- Career planning.
- A focus on professional and personal growth through training and coaching.
- Room for personal engagement to help shape our company's future.
Evelien Van Eecke