Description
For one of our sponsors, based in Amsterdam West, we are currently looking for a
Clinical Trial Associate. In this role you will be providing support to project teams within the Clinical Development Centre (CDC) in The Netherlands for assigned clinical trials. Activities include all relevant aspects of preparation, execution, and finalisation of a clinical trial in order to facilitate the process towards timely clinical project deliverables of required quality
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 to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
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
During Start-Up:
- Ensure timely delivery of (country specific) documents applicable for submission
- Ensure timely responses to RFIs in collaboration with the project team
- Set-up of Sponsor Trial Master File (STMF) tasks (Country and Site-specific documents) as per responsibility split between CTA (country specific docs) and CRA (site specific documents)
- Timely collection, filing and preparation for long term archival of site and country level trial documents in STMF according to country and company SOPs
- Preparation and shipment of initial Investigator Trial Master Files (ITMFs)
- Enter initial information in relevant clinical IT systems (e.g. COSMOS, CONNECT Portal) as per responsibilities split
- Perform quality control (QC) of trial documents such as review and translations, e.g. patient information
- Ordering clinical supplies (e.g. booklets, equipment)
- Prepare and maintain study specific logs
- Support in preparation of essential documents (e.g. clinical trial agreements), have them signed and handled in relevant systems
Conduct And Close-out Stages
- Ensure preparation and submission of changes to clinical trial application
- Ensure timely responses to RFIs in collaboration with the project team
- Maintenance of Sponsor Trial Master File (STMF) tasks (Country and Site-specific documents) as per responsibility split between CTA (country specific docs) and CRA (site specific documents)
- Ensure sufficient clinical supplies and adequate tracking
- Support CRAs in distribution of trial documents to trial sites (e.g. Investigator Trial Master File, recruitment material)
- Update and maintain relevant information in the clinical IT systems (e.g. COSMOS, CONNECT Portal)
- Support organisation of local study related meetings (e.g. Investigator meetings)
- Support complaint handling of trial material
- Active involvement in project meetings, for CTA related topics
- Ensure timely and adequate STMF archiving at closeout
Functional Accountabilities
- Oversight of all trial documentation for assigned clinical trials in close cooperation with TM/CRA/Start-up within the CDC
- Ensure and drive consistency in CTA activities across projects and within CDC-NL
Qualifications
What we’re looking for
- An enthusiastic new colleague!
- Previous experience within clinical trials
- Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
- Strong organizational skills and the ability to manage time and work independently.
- High proficiency with full MS Office Applications.
- Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
- Fluency in Dutch and a high level of competence in English language
- Ability to work from the Amsterdam office one or two days per week.
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 as 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.
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