Principal Clinical Scientist, Clinical Science

hace 2 meses

Madrid, España Precision for Medicine A tiempo completo

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

**Position Summary**:
**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 & cleaning.
- Support & participate in the development & implementation of process flow for integrated, cross-functional, data cleaning for interim &/or final study data deliverables between all applicable departments (e.g., data management, medical, safety, vendors, sponsor, etc.)
- May be responsible to cross-functionally manage the overall data cleaning process internally to support interim &/or final data deliverables (e.g., tier cleaning process/timelines, etc.)
- Provide protocol review from a scientific operational perspective.
- Provide indication-focused, scientific, clinical input & support to Data Management in the development & revision of eCRF specifications, edit checks & completion guidelines &/or other study-specific documentation as applicable.
- Provide indication-focused, scientific, clinical input & 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 & Financial Management on monthly invoicing & 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 &/or develop & maintain CSAI project related plans, guidelines, & trackers
- Ensure applicable eTMF documentation related to CSAI is maintained as per study project plans & SOPs.
- Support &/or conduct holistic &/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 &/or graphs.
- Oversee &/or issue & resole queries in various EDC systems.
- Review &/or provide routine status updates on CSAI data review findings & escalate issues as appropriate.
- Manage &/or conduct the development & associated User Acceptance Testing (UAT) of CSAI programmed output(s)
- Provide study-specific training for CSAI Scientists, project teams &/or study sites based on review findings.
- Participate in internal & external study-specific team meetings &/or presentations as applicable including facilitating CSAI meetings or topics.
- May support study-specific data related committees &/or meetings (e.g., safety review committee)
- May conduct review of Table, Figure & Listings (TLFs) &/or clinical study reports (CSRs)
- May participate in business development activities including proposal development & client presentations as applicable.
- Performs other duties as assigned by management.

**Qualifications**:
**Minimum Required**:

- Bachelor's degree or equivalent combination of education/experience in 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**:

- Experience in trial phase 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 & oral
- Working knowledge of FDA & ICH/GCP regulations and guidelines.
- Ability to occasionally travel domestically & internationally including overnight stays

**Highly Preferred**:

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

**Competencies and Skills**:

- Desire to continually learn & keep up to date on medical & oncology standards of care with the ability to self-research & educate.
- Working knowledge of FDA & ICH-GCP, relevant SOPs & regulatory guidance with a well-rounded knowledge of the entire clinical trial process & working understanding of clinical research functional departments
- High level of integrity from a professional & ethical perspective
- Ability to independently manage the CSAI operational function in a global, cross-functional environment with awareness of appropriate escalation.
- Exhibits self-motivation with the ability to work remotely while independ

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