Global Senior Project Specialist (Sponsor Dedicated). Spain, UK, Germany, Netherlands, Belgium,[...]

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.
• Attend, participate, prepare and distribute meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings).
• Follow up with team members on action items to closure.
• Maintain timely and effective communication among team members and site staff.
• Keep 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:

• Associate's degree (or equivalent) in life sciences, medicine, pharmacy, nursing or a 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 the ability to inform, influence, convince, and persuade.
• Ability to travel if necessary (approximately 5 %).
• High level of competence in English language.

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 will determine what constitutes equivalent to the qualifications described above. 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:

Roles within the Clinical Project Management job family are responsible for planning, directing, creating and communicating clinical study timelines. They gather input from cross‑functional teams and create plans that help the team produce deliverables on schedule. They ensure consistency of clinical study processes across trials, oversee and resolve operational aspects in conjunction with project teams, and follow standard operating procedures, good clinical practice (GCP) and specific country regulations. They may develop trial recruitment strategies and support the clinical development strategy as outlined by the clinical teams.