Sponsor Dedicated Global Senior Project Manager (CTL level role) remote

Syneos Health Austria GmbH; Österreich; Remote; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Syneos Health Austria GmbH in Austria is seeking a Sponsor Dedicated Global Senior Project Manager (CTL level) for a remote role. You will lead global clinical trials, ensure compliance with GCP/ICH, and partner with clients to deliver speed and value across trials.

This CTL role requires strong leadership, global experience, and the ability to manage timelines and budgets. Travel up to 25% may be required; you will line manage PMs and collaborate across functions to drive study delivery.

Qualifikationen

• Bachelor’s Degree in life sciences or equivalent.
• CRO experience preferred.
• Strong knowledge of Good Clinical Practice/ICH guidelines and regulatory requirements.
• Prior experience leading global clinical trials.

Aufgaben

• Lead trial projects within the Evidence Network ensuring timely start, conduct and closeout per contract.
• Oversee project teams, ensure quality, timelines and budget management.
• Coordinate study activities with partners and manage study documentation (TMF) and regulatory readiness.
• Develop contingency plans and risk mitigation to ensure delivery goals.

Kenntnisse

Clinical trial leadership

Global experience

GCP/ICH knowledge

Communication skills

Travel readiness

Ausbildung

Bachelor's degree in life sciences or related field

Jobbeschreibung

Sponsor Dedicated Global Senior Project Manager (CTL level role) remote 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.

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 building an inclusive culture – where you can authentically be yourself.
• Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with.

Job Responsibilities

For one of our single client partnerships we are looking for a Clinical Trial Leader. The CTL is a key member of Clinical Delivery Team nominated to a specific trial within the Evidence Network. CTLs are accountable for the set-up, execution and delivery of their assigned trial(s) and contribute to delivery of our clients pipeline through accurate planning and efficient execution of trials that bring speed & value to participating subjects and sites.

Project Leadership and Delivery. Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements. Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement. Lead project team to ensure quality, timelines and budget management. Accountable for the financial performance of each project. Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues. Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements. Accountable for all project deliverables for each project assigned. Responsible for quality and completeness of TMF for assigned projects. Accountable for maintenance of study information on a variety of databases and systems. Responsible for study management components of inspection readiness for all aspects of the study conduct. Oversight for development and implementayion of project plans. Developing contingency planning and risk mitigation strategies to ensure sucessful delivery of study goals. Develops strong relationships with current clients to generate new and/or add-on business for the future. May participate in bid defense meetings where presented as potential project manager. May be required to line manage other project management team members and clinical monitoring staff.

Qualifications

• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
• Clinical research organization (CRO) and relevant therapeutic experience preferred.
• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements Prior experience leading global clinical trials
• Strong organizational skills.
• Strong global experience.
• Strong ability to manage time and work independently.
• Direct therapeutic area expertise.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken.
• Ability to travel as necessary (approximately 25%).

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.

Discover what our Syneos Health colleagues already know: work here matters everywhere.

Learn more about Syneos Health. http://www.syneoshealth.com

We 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.

Discover what our 29,000 employees already know: work here matters everywhere.

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.

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. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most.