Clinical Study Physician - Oncology - FSP

Parexel•New York, CT

3d•Remote

About The Position

Parexel FSP is hiring a fully remote Clinical Study Physician with oncology experience. The Study Physician is a qualified, clinically experienced physician who holds medical responsibility for clinical trials throughout preparation, conduct, and reporting. The role provides medical oversight from Trial Design Outline kickoff through the Clinical Trial Report and is a core member of the Trial Team and Evidence Network Team. During trial start-up, the physician contributes medical expertise to protocols and updates, risk-based quality management, monitoring plans, important protocol deviations, trial documents, data-management materials, patient information and informed consent, training and communication plans, and statistical analysis plans. The role also contributes to patient narratives, trial report planning and review, regulatory and ethics committee responses, feasibility, recruitment and retention planning, and medical training. During trial conduct, the physician performs and documents ongoing medical review, monitors critical data and clinical quality risks, escalates issues, responds to medical queries, engages with sites and experts, and supports relevant adjudication, monitoring, safety, and steering committees. The role may also contribute to trial newsletters and scientific publications. The physician manages medical activities for one or more trials and contributes to cross-functional clinical program planning, execution, and analysis. The role requires compliance with Parexel processes, ICH-GCP, applicable requirements, and internal standards, as well as completion of required training and administrative tasks.

Requirements

Physician MD, ideally with a medical thesis, and training in a clinical setting.
At least 4 years of active clinical experience.
Oncology experience.
Experience in the pharmaceutical industry or a CRO in medical, project management, global pharmacovigilance, or another relevant medical function; ideally in Clinical Development.
Understanding of relevant regulations and guidance, including ICH-GCP.
Experience with data visualization systems and IT systems.
Proficiency with Windows and Microsoft Office, including Word, PowerPoint, Excel, and Outlook.
Proficiency in written and spoken English and the local language.
Excellent interpersonal, active listening, and influencing skills.
Strong analytical skills and a systematic, well-structured working style.
Strong presentation and training skills.
Ability to work proactively and collaboratively in an international environment.
Ability to use digital technologies to access information, innovate, solve problems, communicate, navigate, learn, and apply knowledge in a digital environment.

Nice To Haves

Specialization in internal medicine or general practice.
Medical thesis.

Responsibilities

Provide medical responsibility and oversight for clinical trials through preparation, conduct, and reporting.
Contribute medical content to clinical trial protocols and updates in collaboration with trial and evidence team members.
Contribute to trial risk-based quality management by identifying medically relevant critical data, processes, risks, and mitigation and monitoring strategies.
Co-author the Clinical Quality Monitoring Plan and contribute to medically relevant monitoring activities.
Provide medical input on important protocol deviations and support trial-team decisions about potential deviations.
Contribute medical input to trial documents, data-management documentation, eCRF design, data review plans, laboratory specifications, and data transfer arrangements.
Provide medical content for patient information and informed consent, monitoring, communication and training plans, and statistical analysis plans.
Contribute to patient narratives, Clinical Trial Report planning and review, and medical responses to regulators and ethics committees/IRBs.
Contribute medical input to study and site feasibility, patient recruitment and retention planning, and medical training.
Perform and document ongoing medical review, including review of aggregated data and mitigation or escalation of identified risks and quality issues.
Identify medical data inconsistencies and practical difficulties in protocol execution, and communicate clinical quality issues collaboratively.
Respond to medical queries from investigators, CROs, and sponsor representatives, and contribute to trial FAQ maintenance.
Build expert networks and contribute to site engagement.
Support endpoint adjudication, data monitoring and safety monitoring boards, and steering committees as applicable.
Contribute to trial newsletters and scientific publications when applicable.
Manage medical activities for one or more clinical trials and contribute to cross-functional planning, execution, and analysis of a clinical program.
Comply with Parexel standards, required training, applicable processes and regulations, and complete timesheets, expense reports, and CV updates as required.