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
Project Administration
- Creates and maintains the Trial Master File Management (TMF) Plan. Routinely reviews the TMF to ensure quality, completeness and inspection readiness
- Coordinates and monitors the activities associated with study deliverables across all applicable internal functional departments and vendors.
- Assists with activities associated with interim analyses, database snapshots and locks, final CSR and study closure
- Assists with identification of and contracting with approved vendors, as necessary
- Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessary
- Assists with development and implementation of change orders
- Assists with resource management and team member transition by collaborating with appropriate
- Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently
Financials/Reporting
- Develops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones
- Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to client or senior management
- Assists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reporting
- Attends financial review meetings to assist with reconciliation and identification of budget overrun
- Reviews and approves invoices from sites or vendors and to the client
Business Development
- Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively.
- May participate in Customer proposal development
- In collaboration with the Project Team, will plan, coordinate and present at internal and external
meetings
Knowledge/Training
- Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
- Develops knowledge of current therapeutic environment
QUALIFICATION REQUIREMENTS
- Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred
- Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred. CRO and relevant therapeutic experience preferred
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
- Strong organizational skills
- Strong ability to manage time and work independently
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade
- Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment
- High level of competency in English language
- Proficiency with MS Office Applications
- Ability to travel as necessary (up to 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.
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.
