Full-Time Senior Clinical Study Manager

Senior Clinical Study Manager leads and manages the cross-functional clinical study team, ensuring delivery of clinical study activities to agreed timelines, budget, and quality.

Responsibilities:

• Lead and manage cross-functional clinical study team, ensuring objectives and responsibilities are met.
• Deliver all clinical study activities to agreed timelines, budget, and quality.
• Identify and document clinical study risks and deliverables.
• Set up and maintain clinical tracking tools and study contact lists (e.g., Sobi study log, clinicaltrials.gov).
• Ensure study insurance documentation is valid.
• Forecast and manage clinical study team resources and budget (up to 20 MUSD).
• Coordinate clinical study activities related to Investigational Medicinal Products (e.g., ordering, labeling, distribution, expiry date extension).
• Coordinate and contribute to key clinical study document delivery (protocols, amendments, CRFs, patient information documents, clinical study reports, project management plans, communication, quality, and risk management plans).
• Review, approve, and archive clinical study documents according to SOPs.
• Identify, define scope for, lead, manage, and follow-up on ESP performance.
• Manage ESP contracts, amendments, and change orders.
• Coordinate/manage investigator/site selection process and approve investigator/site selection.
• Oversee clinical study progress and ensure compliance with SOPs, ICH/GCP, GPP, and regulatory requirements.
• Provide clinical study status updates and escalate issues.
• Set up, maintain, ensure completeness, and archive the trial master file.
• Contribute to process and tool development for resource utilization and quality improvement.

Qualifications:

• University degree in Life/Health Sciences.
• 7+ years' experience planning, conducting, and reporting multicenter, international clinical studies.
• Extensive knowledge of all clinical study process aspects.
• Demonstrated ability to lead multi-disciplinary teams (team building, negotiation, conflict resolution).
• Experience leading global clinical outsourcing and working with external service providers.

Skills:

• Proactive, committed, and energetic
• Strong leadership and coaching skills
• Excellent communication & interpersonal skills
• Problem-solving skills
• Strong organizational & multitasking abilities
• Customer-oriented
• Excellent written & oral English

Salary Range: $133,000 - $180,000 annually

Benefits: 401k match, incentives, medical, dental, vision, STD/LTD, life insurance, and health/wellness programs.

What is the last date for applying to the job?

Which countries are accepted for this remote job?