Description
Single Sponsor Associate Clinical Project Director (Program Manager) - 3 days in the Dublin office
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.
Discover what your 25,000 future colleagues already know:
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. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
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Typically manages a team of direct reports and may have indirect reports. Plays a leadership role in team member recruitment, on-boarding and leads ongoing training and coaching of team members.
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May provide input into strategic and operational short- and long-range therapeutic area / functional area plans as appropriate, including supporting alignment and communications to other team members upon implementation.
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Champions Values and Leadership Commitments.
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Responsible for overseeing the successful execution of studies and/or multiple studies within a program or multiple programs, including financial responsibility.
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Responsible for leading or otherwise overseeing study teams related to assigned studies.
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Proactively manages vendor engagement for appropriate third-party oversight at the study-level, including proactive governance.
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Proactively manages stakeholder relationships at the study-level.
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Proactively manages oversight of clinical study execution, including developing operational strategies for the study to optimize execution.
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May actively contribute to and/or represent Clinical Operations at sub-teams as applicable, including providing input and support to Associate Directors / Directors as needed.
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Acts as a manager of managers and individual contributors with a People First approach that focuses on employee engagement, development and team health.
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Responsible for the resource management of assigned studies, including an ongoing assessment of resource needs and optimal deployment of resources to support a fluid ‘One Ops’ workforce.
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Effectively participates and engages in Clinical Operations and/or cross-functional change initiatives.
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Leads and/or engages in Clinical Operations-specific change initiatives, typically therapeutic area- or functional area- specific.
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May have business process owner (BPO) responsibilities and/or serve as a subject matter expert for Clinical Operations processes.
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Encourages an innovative mindset by championing new ideas and initiatives that incorporate best practices, external benchmarking and standardization across Clinical Operations.
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Ensures team’s work complies with established practices, policies and processes, and any regulatory or other requirements.
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Experience needed.
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BA / BS / RN with end to end program management experience, with a solid background in Clinical Trial Management or Clinical Project Management.
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Operating at a high level in a cross-functional study management or related leadership experience in CRO or Pharma, including multiple years’ experience leading and managing study management or project teams.
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
Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across therapeutic areas. Clinical Operations plays a key role in ensuring all clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of our client's products. This individual will manage a team of direct and potentially indirect reports. Oversee and be responsible for the successful execution of studies and/or multiple studies within a program or multiple programs, including financial responsibility. You may act as the business process owner (BPO) and/or serve as a subject matter expert for Clinical Operations processes. You will encourage an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking and standardization across Clinical Operations.
