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.
Education / Qualifications :
Master’s degree (Preferable in Neuroscience, Pharmacology, Psychology), plus 4-6 years of relevant 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