Project Director - Real World Late Phase studies

Description

Project Director for Real World Studies

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
  
  

Job Responsibilities

• Oversee a portfolio or program of projects.
• Ensure all studies within a program or portfolio are conducted to reflect the therapeutic or client specific requirements.
• Represent company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively.
• Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) or appropriate regulatory requirements, and International Conference on Harmonization (ICH) guidelines to fulfil all federal and local regulations.
• Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses.
• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
• Ensure and maintain an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio.
• Apply study specific learning across assigned portfolio of studies/clients.
• Lead and ensure consistency in contingency planning and risk mitigation strategies to ensure successful delivery.
• May lead operational input to proposal development and pricing including proposed operations strategy
• Drive performance improvement, operational efficiencies and innovative strategies
• May provide line management oversight and contribute to leadership of Project Management as an operational and therapeutic area expert
  
  

Qualifications

What we’re looking for

• BA/BS in the life sciences, nursing degree, or equivalent combination of education and experience.
• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements, i.e. GPP
• Strong organizational skills.
• Strong ability to manage time and work independently.
• Direct therapeutic area expertise.
• Proficiency with full MS Office Applications, including MS Project
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• 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. 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.