[Hiring] Project Specialist @Syneos Health

Role Description

Project Specialist (Sponsor dedicated) - Mexico, Remote

• Set-up, maintain and/or close out project files and study information (e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.
• Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure.
• Maintains timely and effective communication among team members and site staff. Keeps Project Leadership and Clinical Research Associates (CRAs) fully apprised of sites and study status. May contact site staff as needed for critical information.
• Provide administrative support to Project Leads and functional leads.
• Ensure all study documents are archived based on the appropriate guidelines and policy.
• Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.

Qualifications

• Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.
• Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
• Strong organizational skills.
• Ability to manage time and work independently.
• High proficiency with full MS Office Applications.
• Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Ability to travel if necessary preferred (approximately 5%) to Syneos and/or client's offices.
• High level of competence in English language.
• Portuguese or French knowledge will be highly valued.

Benefits

• 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.
• We are continuously building the company we all want to work for and our customers want to work with.

Company Description

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.