【Study/ site management】
※ Plans, executes and oversees clinical trials to ensure timely completion of the investigation, from study start-up, IRB/ regulatory submission, budget negotiation and agreement execution, to site management.
※ Manages sites by supporting IRB/ regulatory submissions (including amendment, annual renewal, safety reporting), conducting monitoring visits (including site qualification, initiation, monitoring and close-out) and keeping regular contacts to ensure trials are executed in accordance to protocol, SOP and other applicable requirements, and milestones are achieved.
※ Develops or provides input into the required clinical documents (such as project schedule, Clinical Investigational Plan, Patient Informed Consent, study budget/ contract, study training materials and study reports) in collaboration with investigators and the cross-functional study team to meet business needs.
※ Critically evaluates study progress and metrics. Collaborate with cross functional team (local and global) to identify risks and mitigation plans.
【Collaboration】
※ Cultivates strong relationship with clinical investigators and site staff to ensure high quality in trial execution.
※ Collaborates with leadership to assure successful project delivery.
※ Interfaces with key functional areas in order to align the clinical study with needs for other business areas (Marketing, research, regulatory, development, patient management, reimbursement.)
※ Facilitates or leads project meetings including external health care professionals and internal (local and global) cross-functional stakeholders.
【Business acumen】
※ Develops therapeutic and device operation knowledge and applies this knowledge to clinical study processes.
※ Evaluates clinical data/ evidence and may determine application of study results. May provide input and support for planning post-clinical activities, educational activities, and market launch of products
※ Supports other projects and duties, and participates in process improvement initiatives as requested by the Clinical Research Manager.
【Physical job requirements】
※ Travels to field sites to supervise and coordinate clinical study activities, and attend oversea meetings.
※ Expects to have some out of hours and on-call work when required.
【Required skills】
o Tertiary education in medical/ biological/ science/ nursing or equivalent field
o Experience in clinical research : 4-7 years, experience in medical device is an advantage,
o Strong interpersonal, communication and negotiation skills
o Problem solving, multi-tasking
o Detail-oriented
o Able to work independently and as a team
o Proficient knowledge of clinical research study processes and study design; demonstrated ability to incorporate and adhere to Good Clinical Practices and local regulatory standards. Nice to have ISO 14155 knowledge.
o Proficient knowledge in EDC, word processing, spreadsheets, database applications (e.g., Excel), and/ or PowerPoint.