Clinical Study Physician – Oncology

This is a fully remote position, open to applicants in Connecticut.

📋 Description

• Oversee the medical aspects of clinical trials from preparation through to reporting.

• Create and review Clinical Trial Protocols and any updates to protocols.

• Provide medical insights for trial risk-based quality management and monitoring strategies.

• Offer medical guidance on critical protocol deviations and trial-related documentation.

• Assist in the creation of data management documentation, eCRF design, data review strategies, laboratory specifications, and data transfer agreements.

• Develop medical content for patient information, informed consent forms, monitoring manuals, communication and training plans, and statistical analysis plans.

• Participate in patient narratives and contribute to the planning and review of Clinical Trial Reports.

• Address inquiries from regulators and Ethics Committees/IRBs.

• Provide medical input for study and site feasibility, as well as recruitment and retention strategies.

• Conduct medical training for country feasibility teams, trial investigators, or sponsor personnel.

• Perform ongoing medical reviews and document findings and solutions.

• Implement clinical quality monitoring, risk mitigation strategies, and escalate any clinical quality issues.

• Identify discrepancies in medical data and challenges in executing protocols effectively.

• Respond to medical inquiries from investigators, CROs, and sponsor representatives.

• Build expert networks and enhance site engagement.

• Assist with Endpoint Adjudication, Data Monitoring Committees, Data Safety Monitoring Boards, and Steering Committees.

• Review Trial Newsletters and contribute to scientific publications.

• Manage medical tasks for one or more clinical trials.

• Lead the cross-functional planning, execution, and analysis of clinical programs.

• Ensure the quality of medical assessments, decisions, and processes for trials and assets.

• Complete necessary training, timesheets, expense reports, and CV updates.

• Stay updated on and adhere to Parexel processes, ICH-GCPs, and relevant regulations.

⛳️ Requirements

• Experience in oncology.

• A qualified and clinically experienced physician.

• MD degree, preferably with a medical thesis, trained in a clinical environment.

• At least 4 years of active clinical experience.

• Specialization in internal medicine or general practice is preferred.

• Experience in the pharmaceutical industry or CRO in medical, project management, global pharmacovigilance, or similar medical roles, ideally within Clinical Development.

• Familiarity with relevant regulations and guidelines, including ICH-GCP.

• Experience with data visualization tools and IT systems.

• Proficient in Windows and MS Office applications (Word, PowerPoint, Excel, Outlook).

• Fluency in written and spoken English and the local language.

• Strong interpersonal, active listening, and influencing abilities.

• Excellent analytical capabilities, systematic, and well-organized work style.

• Strong presentation and training skills.

• Ability to work proactively and collaboratively in an international setting.

• Competence in utilizing digital technologies for information access, problem-solving, communication, navigation, learning, and knowledge application in a digital landscape.

🏝️ Benefits

• Equal opportunity employment.

• Required training curriculum.

• Adherence to Parexel processes, ICH-GCPs, and other applicable regulations.