Job ResponsibilitiesThis role will support late phase Hematology and Immunology portfolios.
The PM II provides support to the Clinical Trial Manager/operational team in execution of the trial(s). These responsibility will 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 tasks will include reviewing, developing, and writing clinical trial documents and manuals, including study manuals, laboratory or biomarker plans, and other supporting documents, plus 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.
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.
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.
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