Clinical Project Associate België
il y a 2 semaines
Updated: December 23, 2024
Location: Belgium-Europe - BEL-Home-Based
Job ID: 24006979
For one of our single sponsor business units, we are currently recruiting for a Senior Clinical Operations Specialist to be based in Belgium.
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.
Why Syneos Health
• We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition; and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities
• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions.
• Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies and communicating with sites to ensure compliance with protocol requirements, study procedures, and relevant guidelines.
• Creates and assists with maintenance of project files, handles project correspondence.
• Participates in file audits.
• Prepares and maintains site manuals, reference tools, and other documents.
• Maintains, updates, and inputs clinical tracking information into databases.
• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client.
• Manages shared mailbox, processes site requests, and routes correspondence appropriately.
• Coordinates the ordering, packaging, shipping, and tracking of site supplies and materials.
• Assists with coordination of team meetings, attends meetings, and prepares accurate meeting minutes and action items.
• Routinely anticipates, identifies, and resolves potential issues and implements corrective actions, seeking guidance as needed to resolve more complex issues.
• Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training.
• May provide training or mentorship to more junior level Clinical Operations Specialists (COS).
Qualifications
What We’re Looking For
- Bachelor's degree in a scientific/medical discipline.
- Minimum of two years of experience in a scientific/clinical related field is preferred.
- Experience in Multiple Sclerosis, Neurology/Immunology is preferred.
- Good knowledge of medical terminology, clinical data, and ICH/GCP preferred.
- Ability to successfully prioritize and work on multiple tasks.
- Strong attention to detail, accuracy, and organizational skills.
- Excellent communication, presentation, and interpersonal skills.
- Fluency in Dutch and French and strong in English.
- Ability to embrace new technologies.
- On commuting distance to the Diegem sponsor office.
Get to Know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world.
Syneos Health is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies, and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We
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