Essential functions and responsibilities
* lead the successful execution of clinical trials from protocol concept to clinical study reports in support of complex oncology programs.
* ensure inspection readiness by maintaining comprehensive study documentation and files.
* organize and lead study and departmental meetings, including minute-taking and document archiving.
* coordinate clinical trial equipment, supplies, and cross-functional project activities (e.g., clinical data review meetings).
* ensure team compliance with study-specific training and perform tmf reviews for completeness.
* support clinical sites in audit and inspection preparation.
* assist with budget management and daily clinical operations, ensuring adherence to sops, ich/gcp, and regulatory requirements.
* monitor subject and site activity/metrics and perform quality checks across study components.
* proactively identify, troubleshoot, and escalation issues impacting deliverables.
* contribute to study set-up activities including protocol/synopsis development, informed consent forms, system configuration (ctms, irt), regulatory submissions, and operational documentation.
* collaborate with cros to ensure timely collection and archiving of tmf documents.
* partner with regulatory affairs on essential document submissions.
* support study close-out activities including tmf and drug reconciliation and csr readiness.
* foster effective communication and collaboration with study team members, clinical trial managers, and asset leads.
* participate in process improvement and quality initiatives related to study execution.
* other duties as deemed necessary.
required education, experience, skills, and abilities
* bachelor’s degree with at least 5 years of hands‑on clinical trial experience, within a pharmaceutical or biotech environment. A combination of cro and sponsor‑side experience will be considered.
* demonstrated experience in oncology trials, including trial set‑up, monitoring, and close‑out.
* global clinical trial management experience, especially in the eu, highly desirable.
* strong working knowledge of ich/gcp regulations.
* proficiency with electronic systems such as etmf, ctms, edc, etc.
* ability to work independently and thrive in a collaborative team environment.
* strong critical thinking skills, a sense of urgency, and a proactive problem‑solving mindset.
* excellent interpersonal, written, and verbal communication skills.
* proficiency in ms office and comfort with technology.
* minimal travel required (0 to 5%).
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