Associate Director, Risk-Based Clinical Monitoring

Location: 

Remote - United States, US

 

The purpose of Idorsia is to discover, develop and bring more, innovative medicines to patients. We have more ideas; we see more opportunities and we want to help more patients.  In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

 

Headquartered near Basel, Switzerland, the US Commercial Operations & Clinical Development teams are based near Philadelphia, Pennsylvania.  Idorsia is committed to meet the changing needs of healthcare professionals, patients and their families.  The core of what we do is to bring creative solutions to the market based on our science and data.

 

During the past two decades, the complexity of clinical trials has grown, creating new challenges to clinical trial oversight. Risk based monitoring focuses on preventing or mitigating risks to data quality and trial integrity related to increased variability in clinical investigator experience, site infrastructure, treatment options and geographical dispersion.

 

Idorsia is searching for a Risk-Based Monitoring Lead to develop a global risk-based monitoring strategic framework in collaboration with global clinical operations, biometrics & data management.  The successful individuals will partner closely with local affiliates to influence and manage change from existing monitoring processes and philosophies.

 

Key Responsibilities:

 

  • Provides overall guidance and contributes to development of Risk-Based Monitoring process in clinical trial management and related procedures at Idorsia on a global level
  • Leads Risk-Based Monitoring activities in accordance with SOPs, regulations, guidelines, policies and good clinical practices.
  • Provides a clear risk-based monitoring plan for all projects
  • Identify and quantify trends and issues for all sites (worldwide)
  • Design tailored solutions to track study trends and issues
  • Analyze the trends and issues to understand the root causes
  • Identify and Analyze patterns based on the site’s specificities
  • Helps implementation of Quality by Design from study startup to database lock and works closely with the data managers and country operation managers to ensure appropriate cross-team delivery of risk-based monitoring throughout the duration of the study.
  • Facilitates relevant discussions with the study team, while working closely with all functions involved to assure alignment on the Quality Threshold Limits and the Risk-Based approach to monitoring with proper documentation of actions and accountabilities.
  • Assists in vendor oversight and ensures appropriate documentation and follow-up of plan.
  • Maintains an on-going overview of the study and site-level risks and issues and defines relevant actions/processes with collaboration of the study team.
  • Reviews the quality and integrity of study data through a remote/central review of data trend reports to identify any data issues and develops appropriate corrective or mitigation plans to the study monitoring plan with data management and operational team members.
  • Proposes adjustments to study, country, and/or site level Source Data Verification or Source Data Review, as appropriate, within the electronic Data Capture systems based on quality trends.
  • Ensures appropriate actions are taken by global/local teams to investigate, resolve and document risks identified via data review, including adequate documentation of resolution.
  • Performs ongoing assessment of the effectiveness of the Risk Mitigation activities
  • Support inspection and audit readiness activities.

 

Qualifications:

 

  • Bachelor’s degree from an accredited university in Science, Biostatistics, Data Management, or related fields.  Will consider Master’s degree in lieu of experience.
  • 8 years’ experience working in a pharmaceutical or CRO environment in a clinical operation, data management or biometric role with some or all of that time in a risk-based model.
  • Must have experience in the development, implementation, or oversight of risk-based monitoring in a clinical study.
  • Experience in remote or on-site monitoring, data management or data analysis related to clinical trials.
  • Experience in a matrixed environment & cross-functional teams with groups of people with diverse background, skill sets and personalities.
  • Excellent collaboration, communication skills (oral as well as written) and leadership skills. Ability to work in project teams
  • Proficiency in analysis packages (e.g., R, SAS) and/or electronic Data Capture systems preferred.

 

 

At Idorsia, we harness the power of difference, authenticity and inclusion to achieve business success. We are committed to fostering respect, fairness and equal opportunities for all job applicants and all our employees.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

 

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you will be informed in greater detail in due course.

 

Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, please note that all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.


Nearest Major Market: Eugene