Country Study Start-up Specialist
il y a 2 semaines
Country Study Start-up Specialist (NL/FR/EN):
- Location:
- Contact:
- Job type:
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- Industry:
Are you a Junior with a Master degree in Life Science and are you eager to build up a career within clinical research?
Or do you have previous clinical research experience and would like to be more involved in the start-up phase of clinical trials?
Then this may be for you
The Country Start-up Specialist will, for assigned sites/study(s), ensure successful protocol level execution of start-up and regulatory activities, manage ethics and other local submissions in Belgium, and provide Local regulatory expertise.
Responsibilities
- Responsible for study timelines and submission strategy, tracking start up progress and reporting metrics. Anticipate and identify country/site issues that could affect timelines and develop alternative solutions.
- Ensure database containing regulatory/ethics requirements is up to date.
- Maintain sponsor Trial Master File and Investigator Site File for the documents under his/her responsibility, ready for inspection, according to company processes and procedures. Collect essential documents as defined by internal processes.
- Facilitate customization of Informed Consent Forms, patient facing materials, and other recruitment materials at country and/or site level.
- Facilitate customization of Study Budgets, for ethics submissions. Collaborate with local contracts team to execute agreements.
- Ensure clinical trial management systems containing all country and sitespecific information are maintained and kept current during start up and study maintenance.
- Manage translations needed for regulatory activities.
- Responsible for site activation activities, including but not limited to Investigational Product Authorization, Activation in Systems, and communication readiness to enroll.
- Point of contact for Regional/Area roles, to proactively drive start up for Belgium.
- Responsible for collection or customization of documents needed for amendment submission, Informe Consent Form updates, Principal Investigator changes, Site Relocations, or others.
- Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Client Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.
- Ensure audit and inspection readiness of assigned sites/studies. Advise on preaudit activities for GCP requirements. Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
- May be responsible for being the country point of contact for submission activities for CRO managed study.
- May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.
- Builds professional and collaborative relationships with peers and site monitors.
Requirements:
- Education: University degree in Life Sciences
- Experience in clinical research is an asset
- Good language skills in Dutch and French and English
- Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
- Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity.
- Demonstrated proactive and positive team player.
- Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
- Demonstrated business ethics and integrity.
- Existing right to work in Europe required
Benefits
- Balanced salary package based on your skills and experience
- Flexibility homeworking/office policy
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