25108671 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.
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 (AE)/Serious Adverse Events (SAE), 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 (approximately 5%) preferred.
High level of competence in English language.
Summary The Project Specialist is a key member of the Clinical Trial Team and is accountable for clinical trial execution excellence including any of the following: planning, coordination and conduct of complex, regulatorily defined tasks; seamless trial operation and communication to all applicable stakeholders; timely delivery of all the materials, documentation and information needed to set up, execute and deliver the assigned trial(s); independently take care for complex technical systems to manage clinical trials; oversight of trial supplies, documentation, submissions, and other operational parameters.
The Senior Project Specialist is responsible for maintaining and coordinating the logistical aspects of clinical projects, and provides overall support to functional leads to ensure the successful completion of project deliverables. The Senior Project Specialists supports the Project Lead (PL) to ensure the contracted services and expectations of assigned projects are carried out by the project teams in accordance with executed contracts and the customers’ requirements. Operate independently, with minimal day to day oversight, and may co‑ordinate the activities of Project Specialists.
EEO Statement The Company is committed to compliance with the Americans with Disabilities Act, and to the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
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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.
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 (AE)/Serious Adverse Events (SAE), 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 (approximately 5%) preferred.
High level of competence in English language.
Summary The Project Specialist is a key member of the Clinical Trial Team and is accountable for clinical trial execution excellence including any of the following: planning, coordination and conduct of complex, regulatorily defined tasks; seamless trial operation and communication to all applicable stakeholders; timely delivery of all the materials, documentation and information needed to set up, execute and deliver the assigned trial(s); independently take care for complex technical systems to manage clinical trials; oversight of trial supplies, documentation, submissions, and other operational parameters.
The Senior Project Specialist is responsible for maintaining and coordinating the logistical aspects of clinical projects, and provides overall support to functional leads to ensure the successful completion of project deliverables. The Senior Project Specialists supports the Project Lead (PL) to ensure the contracted services and expectations of assigned projects are carried out by the project teams in accordance with executed contracts and the customers’ requirements. Operate independently, with minimal day to day oversight, and may co‑ordinate the activities of Project Specialists.
EEO Statement The Company is committed to compliance with the Americans with Disabilities Act, and to the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
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