Clinical Study Manager
- North America, All US
- Contract
- Drug Safety / Pharmacovigilance
We have an exciting opportunity with an Australian based client who’s focus on the research, development, and commercialisation of products helps patients who haven’t yet received necessary care. You would contribute to their portfolio of life changing products as a Clinical Study Manager in their newest facilities.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Act as a patient advocate throughout the clinical development project lifecycle, with a mindset to minimize patient and site burden when participating in clinical trials.
- Understand and support trial milestones including site identification and assessment, patient/subject recruitment, Key Opinion Leader (KOL) and Steering Committee development, and medical affairs support as required.
- Coordinate internally with Medical and Quality Assurance to identify risks to clinical trial projects.
- Participates in the development of study timelines, in coordination with the internal study team and external partners. Manages the trial according to agreed timelines.
- Bachelors with experience in clinical research, with at least two years of clinical project/study management.
- Experience qualifying & managing external vendors (e.g. CRO, Call Center, Central labs, etc.).
- Experience managing clinical project team personnel.
- Experience leading operational teams through the start-up, study conduct, data management, and report writing of clinical studies.
- Experience liaising cross-functional teams internally and with external partners to align on program expectations.
- Fluent in Chinese
#LI-KT1
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
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