Full-Time Senior Clinical Study Manager

Senior Clinical Study Manager leads and manages cross-functional clinical study team.

Ensures delivery of clinical study activities to agreed timelines, budget, and quality.

Ensures knowledge of patient needs, clinical landscape, and operational feasibility. Builds relationships with investigators, site personnel, ESPs, external parties, and Sobi affiliates.

Leads and manages the cross-functional clinical study team, ensuring objectives and responsibilities are met.

Ensures delivery of all clinical study activities to agreed timelines, budget, and quality.

Identifies and documents risks to clinical study activities and deliverables.

Sets up and maintains clinical tracking tools and study contact lists (e.g., Sobi study log, clinicaltrials.gov).

Ensures study insurance documentation is valid.

Forecasts and manages clinical study team resources and budget (up to 20 MUSD).

Coordinates clinical study activities related to Investigational Medicinal Products (ordering, labeling, distribution, expiry date extension).

Coordinates, contributes to, and ensures delivery of key clinical study documents (protocols, amendments, CRFs, patient information documents, clinical study reports, project management plans).

Reviews, approves, and archives clinical study documents according to Sobi SOPs.

Identifies ESPs for clinical study activities, defines scope, leads/manages ESPs, and follows up on performance.

Manages ESP contracts, amendments, and change orders.

Coordinates/manages investigator/site selection process and approves selections.

Oversees clinical study progress, ensuring compliance with Sobi SOPs, ICH/GCP guidelines, GPP guidelines, and regulatory requirements.

Provides clinical study status updates and escalates issues.

Sets up, maintains, ensures completeness, and archives the trial master file.

Contributes to developing processes and tools to improve resource utilization and quality.

Education/Experience:

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

Personal Attributes:

• Proactive, committed, energetic
• Strong leadership and coaching skills
• Strong interpersonal, communicative, and flexible attitude
• Excellent problem-solving skills
• Strong initiative, organization, and multi-tasking abilities
• Customer-oriented mindset
• Excellent written and oral communication skills (English)

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

Benefits: 401k match, short/long-term incentives, medical/dental/vision/STD/LTD/life insurance, wellness programs

What is the last date for applying to the job?

Which countries are accepted for this remote job?