Covance

Clinical Scientist

Job Location(s) AU
Job Number
2021-63178
Job Category
Clinical Pharmacology
Position Type
Full-Time
Telecommute
Yes

Job Overview

- 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 Covance 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 Early Phase Development Solutions (EPDS) 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, Covance 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. 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.

Education/Qualifications

- Master’s degree in an applicable scientific field, plus 4-6 years of relevant experience; or a PhD degree in an applicable scientific field.
- Knowledge of GCPs and regulatory agency guidelines.
- Ability to conduct limited review of related literature and references to obtain the required information and subsequently apply it.
- Skilled in data interpretation.

Experience

- Up to 4-6 years of relevant experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, pharmacokinetic, or data management).
- Additional experience may be substituted for education requirements.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed