Clinical Scientist

**Clinical Scientist / Senior Clinical Scientist - EMEA, Remote**

Labcorp’s Clinical Pharmacology Services team is recruiting for a Clinical Scientist / Senior Clinical Scientist. You will join a global team and have the opportunity to work across a number of compounds across Phase I studies. In a versatile opportunity, you will work closely with a variety of different Sponsors, providing scientific input into development & implementation of protocols and clinical development plans.

2023 is an exciting time to join Labcorp, with a state of the art, clinical research unit opening in Leeds, UK, we are looking for a Senior Clinical Scientist OR Clinical Scientist who is based within EMEA. You will work on a variety of different projects and work closely with a number of different teams across clinical development, from reviewing proposals & attending kick-off meetings through to the oversight of data review and clinical study reports.

Although the role is 100% remote, there would be opportunity to attend client meetings, on occasion, face to face in Leeds, UK.

**Duties will include**:

- 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 Labcorp 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 logístical rationale/input for including biomarkers or other lab markers in Proof-of-Concept (POC) studies.
- Interacts with Labcorp Early Development Solutions and participates on Molecule Development Teams as the early clinical representative.
- 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, Labcorp 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.
- Ensures SAEs are handled appropriately and in a timely manner. Supports Medical Monitor and Project Teams by reviewing SAE reports for completeness.
- 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.

**It is essential you have**:

- Extensive experience as a Clinical Scientist / Clinical Pharmacologist within CRO/Pharma setting.
- Minimum Education Required: Bachelor’s degree in an applicable scientific field, plus extensive relevant experience.
- Knowledge of GCPs and regulatory agency guidelines.
- Skilled in data interpretation.

**#LI-Remote, **Remote, **EMEA**

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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