Description

Global Senior Project Specialist (Sponsor Dedicated) Germany

Job Responsibilities

For one of our single-sponsor partnerships we are currently looking for a Clinical Tral Operations Specialist to join the team here in Germany.

• 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:

• Associates 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

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.

http://www.syneoshealth.com

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.

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 setup, execute and delivery of the assigned trial (s) - independently take care for complex technical systems to manage clinical trials in order to allow a correct reporting of trials to senior management - 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