Senior Clinical Study Manager

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

• • Ensure knowledge of the patients 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 crossfunctional 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 setup 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 followup 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 setup 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 multidisciplinary 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 problemsolving skills and a can do attitude.
• Strong individual initiative organization skills and multitasking abilities.
• Strong customeroriented mindset.
• Excellent written and oral communication skills in English.

Additional Information :

The base salary pay range for this role is $133000$180000 annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary this position is also eligible for a competitive 401k match short and longterm incentives medical dental vision STD/LTD and life insurance benefits in addition to other health and wellness programs and offerings.

The position will be based in United States.

Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex disability age sexual orientation gender identity or national origin. Sobi is committed to providing access equal opportunity and reasonable accommodation for individuals with disabilities in employment its services programs and activities.

Location

The position will be based in United States.

Reporting to

Head of Clinical Program Management US

Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex disability age sexual orientation gender identity or national origin. Sobi is committed to providing access equal opportunity and reasonable accommodation for individuals with disabilities in employment its services programs and activities.

Will be kept confidential according to EEO guidelines.

Remote Work :

Yes

Employment Type :

Fulltime