Global Senior Project Specialist (Sponsor Dedicated) Germany Updated:
Yesterday
Location:
Vienna, 1, Austria
Job ID:
25109737-OTHLOC-3538-2DR
Description Global Senior Project Specialist (Sponsor Dedicated) Germany
Syneos Health® is a leading fully‑integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 deliver – for one another, our customers, and, most importantly, for those in need.
Job Responsibilities
Set‑up, maintain and/or close out project files and study information (e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re‑approvals, data queries) on a variety of databases and systems.
Attend, participate, prepare and distribute meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follow up with team members on action items to closure.
Maintain timely and effective communication among team members and site staff. Keep Project Leadership and Clinical Research Associates (CRAs) fully apprised of sites and study status. May contact site staff as needed for critical information.
Provide administrative support to Project Leads and functional leads.
Ensure all study documents are archived based on the appropriate guidelines and policy.
Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.
Qualifications
Associate’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.
Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
Strong organizational skills.
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.
Ability to travel if necessary preferred (approximately 5%).
High level of competence in English language.
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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Yesterday
Location:
Vienna, 1, Austria
Job ID:
25109737-OTHLOC-3538-2DR
Description Global Senior Project Specialist (Sponsor Dedicated) Germany
Syneos Health® is a leading fully‑integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 deliver – for one another, our customers, and, most importantly, for those in need.
Job Responsibilities
Set‑up, maintain and/or close out project files and study information (e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re‑approvals, data queries) on a variety of databases and systems.
Attend, participate, prepare and distribute meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follow up with team members on action items to closure.
Maintain timely and effective communication among team members and site staff. Keep Project Leadership and Clinical Research Associates (CRAs) fully apprised of sites and study status. May contact site staff as needed for critical information.
Provide administrative support to Project Leads and functional leads.
Ensure all study documents are archived based on the appropriate guidelines and policy.
Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.
Qualifications
Associate’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.
Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
Strong organizational skills.
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.
Ability to travel if necessary preferred (approximately 5%).
High level of competence in English language.
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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