Clinical Scientist III
covance
Madrid, Spain
hace 11 horas

Job Overview :

This is an exciting opportunity with Covance! This position should be based near Basel, Switzerland (+ / - 1 hour) elsewhere in Europe.

The Clinical Scientist provides ongoing in-depth analysis and scientific input into development and execution of protocols and clinical development plans by working with the medical / scientific / regulatory team to creatively solve a wide range of medical / scientific / clinical / regulatory problems.

The Clinical Scientist works with the Medical Monitor / study support on a protocol / program basis for early clinical trials.

Your responsibilties would be :

  • Reviews and evaluates CPS proposals and provides clinical and scientific support, as needed.This includes drafting study outlines / designs and providing guidance on early clinical development strategies.
  • Provides ongoing in-depth analysis and scientific input into development and execution of protocols and clinical development plans.
  • Remains current on issues in scientific expertise through active, ongoing participation in relevant scientific meetings and courses.
  • Works with the medical / scientific / regulatory team to creatively solve a wide range of medical / scientific / clinical / regulatory problems.
  • Establishes and maintains close affiliations with the client and larger scientific community.
  • Provides writing, review, editing and QC of applicable project documents, including :
  • proposals, synopses, protocols, amendments, reports, narratives, investigator brochures,

    informed consent forms, manuscripts, clinical development plans and analysis plans that meet

    scientific and regulatory standards, as applicable.

  • Provides scientific and logistical rationale / input for including biomarkers or other lab markers in Proof-of-Concept (POC) studies.
  • Interacts with Covance / Sponsor Early Phase Development Solutions (EPDS) and participates on Molecule Development Teams as CPS’s representative on studies / programs.
  • Oversee or assist in the planning and conduct of DSMB, Safety Review Committee, Cohort Review, Dose Escalation, Data Review or other medical-related study meetings.
  • Writes draft Medical Responsibility, Safety and other related plans and facilitates their review and approval by Medical Monitor, Project Managers and Sponsors, as needed.
  • Attends Kick-off Meetings & SIVs / Investigator Meetings. Supports training in key medical / scientific areas.
  • Attends Team Meetings. Ensures that any medical / safety issues discussed at the meeting are resolved by the Medical Monitor in a timely manner.
  • Serves as a resource for the Medical Monitor by tracking and reviewing ongoing study-specific safety data (e.g., adverse events, vitals, ECGs and safety lab results) to identify safety trends.
  • Acts as a liaison between the Medical Monitor in all communications between study sties, Covance / Sponsor project staff and Sponsors regarding protocol or other study-related questions, including documenting, tracking and follow-up on all issues.
  • Supports CPS Medical Monitors in tracking and documenting any Inclusion / Exclusion criteria or protocol-related questions and answers.
  • Supports the Medical Monitor in the review and interpretation of data from clinical studies,including data files, tables, figures and listings.
  • Review of study deviations & violations, study data review, adverse events review, concomitant medications review, literature search review, support in iHCP process and CRO / vendor management.

  • Ensures SAEs are handled appropriately and in a timely manner. Supports Medical Monitorand Project Teams by reviewing SAE reports for completeness.
  • Interacts with Covance / Sponsor / 3rd Party safety groups, as needed to support SAE management.
  • Participates in and / or leads process improvement initiatives such as establishing and improving document standards, documentation processes, developing new procedures, process mapping and SOP review / revision.
  • Performs other related duties as assigned.
  • Contribute or lead study team meetings, contribute to the clinical sub team meetings and to team buildings meetings.
  • Other optional activities : review study synopsis and protocol, review eCRF, review ICF / assent forms, SAP review, Lab manual review and of other operational manuals, follow-up adverse events until resolution, follow-up queries from sites until resolution.
  • LI-NC1

    Education / Qualifications :

    Master’s degree (Preferable in Neuroscience, Pharmacology, Psychology), plus 4-6 years of relevant experience

    Experience :

  • Experience in drug development and clinical trials methodology and execution (Phase 0-2 preferable)
  • Knowledge of GCPs and regulatory agency guidelines.
  • Able to acquire knowledge in different disease indications and therapeutic areas
  • Able to collaborate and thrive in a matrix environment and interact with a variety of individuals outside (e.g. investigators) and inside the company (e.
  • g. regulatory affairs, biostatistics, clinical pharmacology, project management)

  • Ability to conduct limited review of related literature and references to obtain the required information and subsequently apply it.
  • Experienced with clinical data review, analysis, interpretation and reporting.
  • Excellent analytical and quantitative skills. Advanced data analysis skills e.g. SPSS, Python, Spotfire are a plus.
  • Strong project-management skills and ability to prioritize task in a dynamic environment
  • Excellent written and oral communication skills in English and is skilled in data interpretation.
  • Strong communication skills and ability to interact in a cross-functional matrix and represent science in study management teams, projects team and across the whole organization
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