Description
Sr. Project Specialist - Buenos Aires Hybrid
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 Management
- Uses performance metrics and quality indicators to assist the Global Trial Lead (GTL) in driving study execution.
- Resolves routine problems and escalates important issues appropriately (with a sense of urgency).
- Actively contributes as a key functional member on cross-functional teams.
Study/Project Planning, Conduct and Management
- Understands study level tools and plans.
- Manages the development and/or collection of study level documentation and supports GTL in ensuring eTMF accuracy and completion for all studies.
- Provides and support input to study level tools and plans while working with moderate to minimal supervision, including but not limited to the Transfer of Obligations to Regulatory authorities. Study SharePoint/study directory updates and the Global Vendor Site List etc.
- Provides operational input and participates in operational processes in support of startup maintenance and close out of studies.
- Assist the GTL in driving study execution.
- Learns, observes and performs core GTA tasks and escalates appropriately.
- Facilitates vendor creation and payment processing in conjunction with the appropriate stakeholders.
- Raises possible issues for potential escalation to the appropriate colleagues.
- Follows instructions, determines level of understanding and seeks clarification when needed.
- Seeks guidance to navigate undefined tasks, challenges, and study tools/resources.
- Supports study specific CSR appendices, as needed.
- Manages global vendor site lists and resolve issues related to global site lists.
- Manages study mail-groups/distributions and SharePoint/Study Directory updates.
- Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols.
- Identifies issues and risks, develops mitigations, and escalates appropriately.
- Participates in filing activities and any associated audits as applicable.
- Lead assigned study closure/archival activities during study closure phase
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.
Summary
• Proactively manages multiple assignments and operational processes with moderate to minimal supervision. • Manages country planning, protocol level attributes and milestones/drivers in CTMS. • Has high functional impact on the study team and the organization.
