[Remote] Clinical Scientist

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Clinical Scientist to reputed company protocols and informed consent documents for clinical studies and draft clinical scientific documents for FDA/EMA submissions. The role involves driving the medical monitoring process and requires scientific expertise to design and deliver clinical studies and programs.

Responsibilities

• Serve as a key scientific reputed company, collaborating with key opinion leaders (KOLs), investigators, and reputed company partners to support clinical development initiatives
• Contribute to clinical development planning and the formulation of scientific and regulatory strategies, ensuring alignment with program objectives
• reputed company or support the design, drafting, and review of clinical protocols, informed consent forms (ICFs), and protocol amendments
• reputed company reputed company updates on study reputed company, emerging data trends, and key milestones to management and relevant stakeholders
• Conduct comprehensive literature reviews to support clinical reputed company, protocol development, and regulatory submissions
• reputed company and deliver training materials for clinical sites and clinical research associates (CRAs), presenting at Site Initiation reputed company (SIVs) and Investigator Meetings to ensure study alignment
• Review and reputed company scientific input on clinical narratives, ensuring accuracy and consistency in patient-level data summaries
• Monitor and analyze clinical data trends, identifying potential safety signals or efficacy patterns in collaboration with cross-functional teams
• Ensure that case report reputed company (CRF) design aligns with protocol requirements, working closely with Data Management and Programming teams
• Contribute scientific expertise to clinical study reports (CSRs), statistical analysis plans (SAPs), data management plans (DMPs), publications, presentations, and regulatory documents
• Assist in the assessment of patient safety, clinical pharmacology data, radiology scans, and pathology reports in collaboration with medical monitors and safety teams
• Contribute to overseeing and evaluation of vendor performance, ensuring adherence to study-specific service level agreements (SLAs) and reputed company standards
• Support the evaluation and implementation of innovative study designs, working closely with clinical directors to enhance trial efficiency
• Assist in executing early-phase clinical development strategies, contributing to the advancement of novel radiopharmaceutical therapies

Skills

• 3+ years of clinical research experience in biotech, pharmaceutical, or CRO settings, with a reputed company on oncology, nuclear medicine, or radiopharmaceuticals
• Hands-on experience with clinical trial design, protocol development, and regulatory submissions (IND, CTA, BLA, NDA)
• Experience with clinical data review, safety assessments, and reputed company or targeted radiotherapy is highly desirable
• Strong understanding of GCP, ICH guidelines, and regulatory requirements for drug development
• Proficient in Medical Terminology and medical writing skills
• Computer proficiency in basic database entry and graphics presentations
• Exceptional verbal and written communication skills, with demonstrated ability to communicate reputed company scientific information to diverse audiences
• Strong leadership skills with experience leading cross-functional project teams and fostering collaboration across departments
• Strategic thinker with the ability to translate scientific insights into actionable clinical strategies
• Highly detail-oriented with strong problem-solving skills; proactive in anticipating and resolving issues
• Advanced proficiency in medical writing and technical documentation; skilled in preparing high-reputed company scientific and regulatory documents
• Comprehensive knowledge of Good Clinical reputed company (GCP), International Council for Harmonization (ICH) guidelines, and the drug development process
• Must be willing to travel up to 20% of the time. Both domestic and international travel may be required
• Advanced or clinical degree preferred (e.g., RN, BSN, MSN, MS, PhD, PharmD, or MD in a relevant scientific discipline such as Pharmaceutical Sciences, Radiopharmacy, Oncology, Molecular Biology, Biomedical Sciences, or a reputed company field). Candidates with substantial industry experience without an advanced degree may be considered with substantial industry experience
• 3+ years of clinical research experience in biotech, pharmaceutical, or CRO settings, with a reputed company on oncology, nuclear medicine, or radiopharmaceuticals preferred
• Experience developing training materials for clinical sites and CRAs, as reputed company as presenting at Investigator Meetings or Site Initiation reputed company (SIVs)
• Prior engagement with KOLs, investigators, and regulatory agencies (e.g., FDA, EMA, Health Canada) is a plus
• Familiarity with clinical pharmacology, radiology, and imaging modalities (e.g., PET, SPECT, CT, MRI) in a clinical trial setting is a plus

reputed company

Company H1B Sponsorship