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

This role will be supporting late phase Hematology and Immunology portfolios.

The PM II provides supporting services to the Clinical Trial Manager/operational team in execution of the trial(s). These services include direct liaison with CROs and other ancillary vendors, as appropriate, to manage relevant trial(s) operational tasks. The Lead maintains effective communication with the project team through oral and written correspondence and status reports to ensure alignment with study timelines. 

Other responsibilities include: reviewing, developing, and writing clinical trial documents and manuals, including study manuals, laboratory or biomarker plans, and other supporting documents. The creation of the Master ICF template and review/approve site changes (in consultation with legal, safety when warranted), plus update template for new risks and new amendments information. 

Essential Requirements
•    Prior sponsor-side experience.
•    Global study experience, rather than experience limited to a single region.
•    Oncology, Hematology, or Immunology therapeutic area expertise, ideally with experience supporting complex or pivotal studies.
 
Important Experience
•    End-to-end study management experience, from study start-up through close-out.
•    Strong communication skills and the ability to work effectively in a fast-paced environment.
•    Experience with study budgets, forecasting, and variance management (CTM only).
 
Key Desired Behaviors & Skills
•    Proactive, takes ownership, and works effectively with minimal direction
•    Strong communication and collaboration skills with internal teams, sites, and vendors
•    Strong prioritization and organizational skills in fast-moving, complex environments
 

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.