Clinical/Sr. Clinical Scientist (Remote; Home-Based)

Essential Job Duties
♦ 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.
Experience
♦ Up to 10-15 years of relevant experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, or data management).
Education
♦ Additional experience may be substituted for education requirements.
♦ Bachelor’s degree in an applicable scientific field, plus 10-12 years of relevant experience; or a 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.
US Pay Range: $120,000-$125,000 USD
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here.
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