Clinical Trial Manager (based in Australia / Singapore)

Minimum Required :

Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred

Minimum of 5-8 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience. Oncology (Phase I) trial experience in Australia preferred

Other Required:

Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)

Excellent communication and interpersonal skills to effectively interface with others in a team setting

Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.

Primary clinical point of contact with the client

Collaborate with PM on monthly invoicing and variance management of clinical budget

Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)

Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings