Manager ds. badań klinicznych

4 weeks ago

United Kingdom Simbec-Orion Group Full time

Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. We are looking for a Senior Medical Director to join our Medical - Clinical Development team where you will provide strategic leadership to the Medical Department, driving process improvement and capabilities across the team whilst ensuring that Clinical Trials are conducted such that subjects' rights, safety and wellbeing are protected and that the Clinical Trial data is reliable. You will assume Medical and Safety oversight for clinical trials conducted by Simbec-Orion and provides medical input when needed.
You will work collaboratively with cross-departmental medical monitoring activities (e.g. clinical operations; project management; regulatory and technical writing) to drive best practice across the organisation.

Leads and manages the Medical Department, reviewing the quality of medical tasks being undertaken by the department, ensuring that standard operating procedures are followed.
Serves as point of contact for both internal and external stakeholders for issue escalation of any medical and safety issue in the study.
Provides Medical and Safety Oversight for the study and conducts medical project governance in coordination with sponsor and internal project manager.
Ensure highest ethical standards in the conduct of clinical trials by ensuring standard operating procedures regularly reviewed and comply with the latest changes in regulations and guidelines.
Acts as Medical Monitor for assigned trials and participate in all stages of the clinical trial development process.
Liaise with other functions in order to ensure client satisfaction through successful execution of clinical projects.
Provide therapeutic area support at all levels within Simbec‑Orion, including the provision of required internal training, and review of study/bid proposals.
Maintain knowledge of trends and changes of importance in the medical management of indications relevant to Simbec‑Orion's projects.

Medical Degree
Experience in medical monitoring, review of patient, laboratory, and safety within a clinical research environment
Previous experience in Leadership role and oversight of a medical team/medical department and related processes
Understanding of financial project management, including departmental budget oversight and revenue recognition
Strong computer skills including but not limited to the knowledge of electronic data capturing systems and MS-Office products such as Excel and Word
Post-graduate Qualification in Clinical Pharmacology / Pharmaceutical Medicine
Experience working in a small/mid cap CRO, biotech or pharmaceutical company

Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company – and your reason to be a part of it.
So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services.

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