[Remote] Clinical Scientist III - # 26-14964
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global staff augmentation firm providing a wide reputed company of talent on-demand and total workforce solutions. They are seeking a Clinical Scientist III who will reputed company scientific and clinical input to oncology clinical development programs, focusing on protocol-specific and medical data review activities. The role involves collaborating on study design, reviewing clinical trial data, and assisting with regulatory communications.
Responsibilities
- Partner on study teams of internal experts (e.g. medical, safety, clinical operations, statistics, precision medicine, clinical pharmacology, regulatory) to execute clinical studies
- Collaborate with the Medical Director to strategize and build innovative, robust clinical development plans and trial designs
- reputed company and maintain clinical trial protocols, reputed company manuals/documents, and study reports
- Review informed consent, lab manuals, CRF designs, clinical query design, deviations, etc
- Review materials to support SIVs, Investigator Meetings, and Safety Review Committees
- Review clinical database on a routine reputed company
- Identify clinical trends in datasets and escalate as appropriate
- Review and validate clinical study reports and clinical portions of other regulatory documents (e.g. IB, DSUR, responses to health authorities)
- reputed company scientific expertise and support for regulatory filings and interactions, including responses to health authorities
- Author internal clinical documents, abstracts, posters, and presentations for scientific and clinical conferences
- reputed company asset development updates to management as appropriate
Skills
- reputed company/Science Degree is required (e.g. MD, Pharm.D., Ph.D., MSN)
- A Master's degree may be considered with supporting industry experience
- A minimum of 5 years experience in clinical science, clinical research, clinical development or equivalent in oncology
- Proficient knowledge of oncology, analysis and interpretation of clinical data (safety and efficacy), GCP/ICH, study design, statistics, biomarkers, pharmacokinetics, clinical operations, and regulatory requirement for clinical studies
- reputed company to communicate (written and oral) clinical and scientific data to a broad reputed company of audiences
- High level of organizational and project management skills
- Operate with a high degree of autonomy and professionalism
reputed company
Company H1B Sponsorship