Senior Clinical Study Manager

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Summer Fridays
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

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

• • Ensure knowledge of the patient´s medical need, current clinical landscape and operational feasibility by building relationships with investigators, study site personnel, External Service Providers (ESPs), other external parties and Sobi affiliates
  • Lead and manage the cross-functional clinical study team and supervise that the objectives and responsibilities within the team are fulfilled
  • Ensure delivery of all clinical study activities in accordance to agreed timelines, budget and quality;
  • Ensure identification and documentation of risks to the clinical study activities and deliverables
  • Ensure that clinical tracking tools and study contact lists are set-up and maintained throughout the clinical study e.g., the Sobi study log and clinicaltrials.gov
  • Ensure that study insurance documentation is valid according to current legislation
  • Forecast and manage the clinical study team resources and budget for individual clinical studies (budgets in the order of up to 20 MUSD)
  • Coordinate the clinical study activities with respect to Investigational Medicinal Products e.g., ordering, labeling, distribution and extension of expiry date
  • Coordinate, contribute to and ensure delivery of key clinical study documents such as clinical study protocols, protocol amendments, case report forms, patient information documents and clinical study reports as well as project management plans (e.g., communication, quality and risk management plans).
  • Ensure review, approval and archiving of clinical study documents in accordance with Sobi Standard Operating Procedures
  • Identify ESPs for clinical study activities and deliverables together with the clinical study team
  • Define the scope for ESPs, lead and manage appointed ESPs and follow-up on ESP performance
  • Identify change of scope requirements to the ESP contracts
  • Manage ESP contracts, amendments and change orders
  • Coordinate or manage the investigator/site selection process, as applicable, and approve the selection of investigators/sites
  • Oversee the progress of the clinical study and ensure that all clinical study activities and deliverables are compliant with applicable Sobi SOPs, ICH/GCP guidelines, GPP guidelines and regulatory requirements
  • Provide clinical study status updates and escalate issues to the Clinical Program Leader
  • Ensure set-up, maintenance, completeness and archiving of the trial master file
  • Contribute to the development of processes and tools to continuously improve resource utilization and quality of clinical study activities and deliverables

Qualifications

Education/Learning Experience/Work Experience

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

Personal Attributes

• A high level of proactivity, commitment and energy.
• Strong leadership and coaching skills.
• Strong interpersonal skills with communicative and flexible attitude.
• Excellent problem-solving skills and a “can do attitude”.
• Strong individual initia