Global Senior Project Specialist (Sponsor Dedicated) Germany

Syneos Health Germany GMBH; Deutschland; Remote; EUR 85.000 - 120.000; Vollzeit

Zusammenfassung

Syneos Health Germany GMBH is seeking a Global Senior Project Specialist (Sponsor Dedicated) to lead trial activities for single-sponsor partnerships in Germany. You will manage study documents, regulatory compliance, and collaboration with CRAs and project leads to ensure timely delivery.

The role requires CRO/pharma background, strong communication, and ability to travel ~5% to sites. Join a global team focused on accelerating patient therapies and building compliant, high-quality trial

Qualifikationen

• Associates Degree or equivalent in life sciences, Medicine, Pharmacy, Nursing or related field.
• Previous experience as Project Specialist within CRO/pharma is essential.
• Knowledge of GCP/ICH and regulatory requirements.
• Global trial experience.
• Ability to travel if necessary (approx. 5%).
• High level of English language and strong communication skills.

Aufgaben

• Set-up, maintain and close out project files and study information (TMF, regulatory docs, enrollment, AE/SAE) across databases.
• Attend and distribute meeting minutes and action items for sponsor and internal meetings.
• Follow up with team on action items to closure.
• Maintain timely communication among team members and site staff.
• Keep Project Leadership and CRAs apprised of site status.
• Contact site staff for critical information when needed.
• Provide administrative support to Project Leads and functional leads.
• Ensure all study documents are archived per guidelines.
• Support QA activities and audits; prepare documentation and drive issue resolution.

Kenntnisse

Strong organizational skills

Global trial experience

Ability to travel

Strong communication & presenting

MS Office proficiency

Independent time management

Ausbildung

Associates Degree or equivalent in life sciences/related field

Tools

MS Office Applications

Jobbeschreibung

Global Senior Project Specialist (Sponsor Dedicated) Germany

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

For one of our single-sponsor partnerships we will in the near future be looking for a Senior 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.
• Previous experience as Project Specialist within a CRO/pharma company is essential to this role
• Strong organizational skills.
• Global trial experience
• 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.

Additional Information

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.

Why Join Us

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.