Senior Project Specialist – Sponsor Dedicated
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Job Description
Senior Project Specialist at Syneos Health managing clinical project files and communications for study information. Collaborating with diverse teams to support clinical solutions for drug development.
Responsibilities:
- 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.
Requirements:
- 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%)
- High level of competence in English language.
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. 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.
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