Principal Clinical Scientist, Clinical Science Analytics

hace 7 días

Madrid, España Precision Medicine Group A tiempo completo

Precision for Medicine is recruiting an experienced Principal Clinical Scientist to work remotely in Poland, Hungary, Serbia, Romania, Slovakia, Spain, or the UK.

Position Summary:

The Principal Clinical Scientist must have a strong working knowledge of medical and oncology standards applicable to clinical trials, preferably in the area of solid and liquid tumors. The Principal Clinical Scientist manages the operational clinical science function from study start-up through database lock for assigned projects focused on scientific and indication-specific insights into data collection and data visualization outputs to support scientific, clinical-sense data cleaning as part of Precision's cross-functional data review team. This role serves as the subject matter expert in the application of clinical knowledge, guidelines, and standards of care to the review of clinical trial data. A medical-related degree is required (RN, OCN, RPH, PharmD, etc.).

Essential functions of the job include but are not limited to:

  • Serve as the functional lead implementing CSAI services per study scope of work (SOW) on assigned project team(s).
  • Serve as a resource for project teams regarding scientific-related data capture, review, and cleaning.
  • Support and participate in the development and implementation of process flow for integrated, cross-functional data cleaning for interim and/or final study data deliverables between all applicable departments (e.g., data management, medical, safety, vendors, sponsor, etc.).
  • May be responsible for cross-functionally managing the overall data cleaning process internally to support interim and/or final data deliverables (e.g., tier cleaning process/timelines, etc.).
  • Manage Medical Monitor review of subject data.
  • Provide protocol review from a scientific operational perspective.
  • Provide indication-focused, scientific, clinical input and support to Data Management in the development and revision of eCRF specifications, edit checks, and completion guidelines and/or other study-specific documentation as applicable.
  • Provide indication-focused, scientific, clinical input and support to Data Management in the conduct of EDC UAT supporting the CSAI function as applicable.
  • Collaborate to support cross-functional departmental communication including internal CSAI communication as applicable on data capture, review trends, EDC updates, CSAI Programming needs, etc.
  • Support the identification of study risks including the management to correct any CSAI study-specific deficiencies.
  • Support Project and Financial Management on monthly invoicing and variance management of the CSAI budget.
  • Collaborate with CSAI management to ensure that CSAI resource needs are adequately addressed due to scope of work changes.
  • Oversee and/or develop and maintain CSAI project-related plans, guidelines, and trackers.
  • Ensure applicable eTMF documentation related to CSAI is maintained as per study project plans and SOPs.
  • Support and/or conduct holistic and/or aggregate scientific, clinical sense data review based on defined manual Clinical Data Review Guidelines using various programmed outputs including but not limited to Smart Patient Profiles, Smart All-Patient-Data Workbook, listings, quality metrics, and/or graphs.
  • Oversee and/or issue and resolve queries in various EDC systems.
  • Review and/or provide routine status updates on CSAI data review findings and escalate issues as appropriate.
  • Manage and/or conduct the development and associated User Acceptance Testing (UAT) of CSAI programmed output(s).
  • Provide study-specific training for CSAI Scientists, project teams, and/or study sites based on review findings.
  • Participate in internal and external study-specific team meetings and/or presentations as applicable including facilitating CSAI meetings or topics.
  • May support study-specific data-related committees and/or meetings (e.g., safety review committee).
  • May conduct review of Table, Figure, and Listings (TLFs) and/or clinical study reports (CSRs).
  • May participate in the interview process of potential new CSAI candidates.
  • May participate in business development activities including proposal development and client presentations as applicable.
  • Performs other duties as assigned by management.

Qualifications:

Minimum Required:

  • Bachelor's degree or equivalent combination of education/experience in a science or health-related discipline with proficiency in medical terminology.
  • Minimum of 8 years of clinical research experience or proven competencies for this position.
  • Minimum of 1 year of leadership experience.

Other Required:

  • Oncology therapeutic experience required, with the ability to apply working knowledge (e.g., understanding of clinical and oncology standards of care and associated side effects, biomarkers, etc.) to data review.
  • Experience in trial phases I, II, and III.
  • On-site monitoring experience and/or data review experience (previous experience as a Clinical Research Associate (CRA) or Study Coordinator or Research Nurse preferred).
  • Experience with electronic data capture systems (EDC) and data visualization tools (such as JReview).
  • Computer proficiency.
  • Professional use of the English language; both written and oral.
  • Working knowledge of FDA and ICH/GCP regulations and guidelines.
  • Ability to occasionally travel domestically and internationally including overnight stays.

Highly Preferred:

  • Medical-related degree, RN, OCN, RPH, PharmD, etc.
  • Database build experience.

Competencies and Skills:

  • Demonstrates highly advanced knowledge in oncology and medical terminology with the ability to apply knowledge to clinical trial data including the application of disease assessment criteria, standards of care, grading criteria, etc.
  • Desire to continually learn and keep up to date on medical and oncology standards of care with the ability to self-research and educate.
  • Working knowledge of FDA and ICH-GCP, relevant SOPs, and regulatory guidance with a well-rounded knowledge of the entire clinical trial process and working understanding of clinical research functional departments.
  • High level of integrity from a professional and ethical perspective.
  • Ability to independently manage the CSAI operational function in a global, cross-functional environment with awareness of appropriate escalation.
  • Excellent time management, negotiation, critical thinking, decision-making, analytical, and conflict management skills with the ability to strategically plan and apply effective risk management.
  • Exhibits self-motivation with the ability to work remotely while independently lead, support, and inspire excellence.
  • Demonstrates the ability to adjust to multiple demands and shifting priorities.
  • Results-oriented, accountable, motivated, cooperative, and flexible.
  • Ability to apply financial management skills at the functional area project level.
  • Excellent presentation, verbal, and written communication skills.
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