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Project Specialist (clinical experience)

Syneos Health
Remote, IND
Full-time
Mid · 5+ years experience
Remote
Discovered 6 days ago
gcp

Full Job Posting

Job Responsibilities

  • Should have min 1 yr of relevant experience.
  • Strong multitasking and organisational skills
  • Excellent communication and interpersonal abilities
  • Ability to work independently and collaboratively
  • Advanced Excel skills for financial review and reporting
  • Planning, directing, creating, and communicating clinical study timelines, ensuring that all milestones are met and that the project stays on track
  • Gathering input from cross-functional teams, including clinical, regulatory, and data management, to create comprehensive plans for timely deliverables
  • Ensuring consistency of clinical study processes across trials by standardizing procedures and implementing best practices
  • Overseeing and resolving operational aspects of clinical trials, including addressing any issues that arise during the study and ensuring that all activities are conducted in compliance with SOP, GCP, and specific country regulations
  • Selecting sites and vendors for clinical trials, negotiating contracts, and managing relationships to ensure high-quality and timely delivery of services
  • Preparing clinical trial budgets, monitoring expenditures, and ensuring that the study remains within budget
  • Monitoring progress of clinical trials, tracking key performance indicators, and following up with team members and line managers to address any deviations from the plan
  • Implementing and preparing the clinical development strategy as outlined by the clinical teams, ensuring alignment with overall project goals and objectives
  • Developing trial recruitment strategies, including identifying target populations, creating recruitment materials, and monitoring enrollment progress

Qualifications:

  • High school diploma or equivalent required
  • Associate's degree or higher in a related field preferred
  • Minimum of 3 years of experience in clinical project management or a related field
  • Strong understanding of clinical trial processes and regulations
  • Experience with SOP, GCP, and country-specific regulations
  • Certifications:
  • Certification in Clinical Project Management or related field preferred
  • Good Clinical Practice (GCP) certification preferred
  • Necessary Skills:
  • Excellent organizational and time management skills
  • Strong communication and interpersonal skills
  • Ability to work effectively in a team environment
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
  • Attention to detail and problem-solving skills
  • Ability to adapt to changing priorities and work under pressure
  • 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.

Preferred Qualifications

  • Associate's degree or higher in a related field preferred
  • Certification in Clinical Project Management or related field preferred
  • Good Clinical Practice (GCP) certification preferred

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