Oxford Global Resources is looking for a highly motivated individual who will join immediately as Clinical Trial Manager (CTM) a global biotech company focused on the development of a diversified portfolio of precision therapeutics that target the Tumor Microenvironment, both directly and through participated companies.
Job Description
CTM will report directly into the Chief Medical Officer that it is also the Medical Director. The role is to lead the operational aspects of the clinical activities of the company. Currently the Company is starting a first-in-human study in cancer patients in Spain and the US. First patient in is expected in Q1 2022. Trial operations are externalized to a CRO that has been already selected.
CTM will be responsible for managing the day-to-day clinical trial process from start-up through close-out activities. CTM should be GCP trained and will oversight the CRO to ensure that is compliant with the procedures and protocol in place and that subject and data integrity is protected. In all tasks, CTM must comply with safety standards and respect privacy and confidentiality.
CTM will interact with clinical staff, review trial progress, and make changes to the trial structure and processes based on subject or team feedback. CTM will be responsible for evaluating the metrics presented by the CRO and capable to design and implement action plans to correct deviations. He/she will be responsible to maintain all the documentation necessary accordingly to regulatory standards and to maintain clinical activities in compliance with local and international regulations.
CTM will participate in the generation of key clinical documents like protocol, ICF and trial manuals. CTM should also be able to communicate to company's management the progress of the trial and to anticipate any issue that may happen.
CTM should be experienced at budget preparation and follow up. Additionally, CTM will perform clinical trial oversight activities in compliance with ICH E6(R2), review data collection policies, storage, and inventory duties.
Responsabilities
- Coordinate and prioritize Trial´s activities and ensure proper execution and conduct.
- Establish and follow up a detailed timeline for each assigned study. Monitor and track progress and obstacles during clinical trial, responding to day-to-day problems.
- Supervise CRO activity in each site, with special emphasis on timeline data introduction in eCRF, sample control and accountability.
- Engage and supervise central laboratories.
- Help in the preparation, oversight and review of study related documents, including protocol, informed consent forms, patient information sheets, pharmacy and sample manuals.
- Coordinate all sample procurement and other required tests according to protocol.
- Track and report on the progress of assigned clinical studies with special emphasis on recruitment and timelines.
- Ensure the quality of Monitoring and that studies are conducted in accordance with the protocol, GCP / ICH guidelines, FDA or EMEA regulations and SOPs.
- Assist with the organization and participate in meetings - i.e. Study Team Meetings, Investigator Meetings.
- Maintain active communication with Site/PIs and team members.
- Oversee and conduct data management and related communication processes.
- Work with vendors and partners to ensure appropriate and timely provision of the investigational drugs involved in the studies.
Requirements
- Bachelor's degree in business management, biology, health care management, or a related field is required for this job.
- Previous experience - including in a managerial capacity - is required.
- CTM must possess excellent communication skills, the ability to multitask, and leadership skills.
- CMT must be a task oriented, an accomplisher and an organized individual that pays close attention to detail and is able to work in a fast-paced environment.
