Senior Project Specialist (Sponsor Dedicated) – Austria/Germany 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. Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure. Maintains timely and effective communication among team members and site staff. Keeps 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 an 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 (approximately 5%) is preferred. 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. 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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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. Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure. Maintains timely and effective communication among team members and site staff. Keeps 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 an 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 (approximately 5%) is preferred. 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. 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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Senior Project Specialist (Sponsor Dedicated) Austria/Germany Arbeitgeber: Syneos Health Austria GmbH
Syneos Health Austria GmbH bietet eine dynamische und unterstützende Arbeitsumgebung, die auf Teamarbeit und Innovation setzt. Als Senior Project Specialist profitieren Sie von umfangreichen Weiterbildungsmöglichkeiten und einer klaren Karriereentwicklung in der spannenden Branche der klinischen Studien. Unser Standort in Österreich und Deutschland ermöglicht Ihnen nicht nur eine abwechslungsreiche Tätigkeit, sondern auch die Chance, an bedeutenden Projekten mitzuwirken, die einen echten Unterschied im Gesundheitswesen machen.
Kontaktdaten:
Syneos Health Austria GmbH Recruiting-Team
