Sr Project Specialist (Sponsor Dedicated/Remote)

Job Responsibilities

• Responsible for planning, coordination and conduct of trial activities according to ICH-GCP.
• Affirms the seamless conduct of trials within the defined timelines in close coordination and communication with the Clinical Trial Leader (CTL).
• Collaborates and interacts with trial team members, Local Clinical Trial Managers (CTM) and interface functions (e.g. Clinical Trial Supplies Unit, Sourcing, others).
• Cooperation with external functions (e.g. Clinical Research Organizations, advisors, investigators) to conduct clinical trials.
• Independently manage correspondence, complex reports, tracking tools and budget overviews in English language.
• Address and answer complex questions from global and local trial teams and trialsites.
• Support the planning of clinical trial supplies.
• Keep overview of records and update of records to address local regulatory demands from Ethics/Authorities to ensure timely submission and re-submission.
• Collaborate in internal/external audits.
• Organize and supervise all trial related wrap-up activities (e.g. data cleaning).
• Ensure the appropriate set-up and maintenance of internal and external systems and tools.
• Support the trial team by compiling data for internal and external reporting purposes and tracking of trial relevant information.
• Proactively engage and contribute to global and local initiatives for improvement in respect to structures, processes, systems and guidelines and development of solutions and new approaches in global context.
• Represent CTOS in working groups and committees, as needed.

Qualifications

• Experience as a Project Specialist at the CRO and Sponsor level clinical trial oversight and responsibilities is preferred in the FSP organization.
• The role is a dedicated representative of the sponsor team in clinical trials.

Skills

• Strong organizational and communication skills.
• Ability to manage multiple projects simultaneously.
• Proficiency in English language.
• Knowledge of ICH-GCP guidelines.
• Experience with clinical trial supply management.
• Ability to work independently and coordinate with cross-functional teams.

Benefits

At Syneos Health, we offer a comprehensive benefits package designed to support our employees' well-being and financial security. This includes:

• A company car or car allowance.
• Health benefits to include Medical, Dental and Vision.
• A 401(k) plan with company match.
• Eligibility to participate in the Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonus based on company and individual performance.
• Flexible paid time off (PTO) and sick time.

Pay

$47,000.00 - $79,900.00

Schedule

Remote