Our client is an innovative robotic medical devices start up.
- Responsible for the oversight and management of all clinical operational activities at the trial and site level. The role will interact and coordinate with the internal team and collaborate effectively with onsite and field staff, clinical research coordinators, principal investigators, and vendors to ensure clinical studies meet or exceed timelines and maintain high quality standards. Demonstrate experience with clinical research study execution, exceptional organizational skills, excellent attention to detail, and work in a fast paced start-up culture
- Develops clinical strategy for products in development in coordination with regulatory (i.e. MDD, MDR, CFDA, pre-market and post-market) and marketing (e.g. reimbursement) strategies
- Manages vendor and CRO activities, and tracks internal and external (CRO/vendor) project deliverables to ensure they remain within the timeline and budget
- Participates in clinical research activities including management of clinical study sites, management of study documentation, and completion of project management tasks
- Prepare and maintain Clinical Study Files including Trial master files (TMF), Investigator Site File (ISF), Investigator File (IF), study essential documents and regulatory (informed consents, IRB approvals, research agreements) documents etc.
- Work with CRO to prepare of EC (Ethics committee) document for submission and other tools, templates and documents before clinical site initiation
- Develops clinical trial timelines, enrollment projections, documents and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
- Participates in and leads process improvement activities within the department and cross functionally, including Quality Management System SOP development
- Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.
- Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs, data management, and CROs
- Upload cases and enter biometrics for assigned clinical studies, as required
- Perform other duties as required for successfully completing studies, as necessary.
- Some travel required; will occasionally conduct site visits, attend investigator meetings, or vendor visits/audits
- Supports all business segment initiatives as identified by management and in support of Quality Management Systems (QMS) and Regulatory requirements
- Complies with international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
- Work closely with a multidisciplinary team to coordinate pilot production of new products and accomplish tasks
- Diploma/Bachelor degree in a scientific discipline (eg. Biology, Chemistry, Microbiology) or health related field
- Minimum of 5 years of clinical affairs experience in the medical device industry
- Experience in registry studies and investigator-initiated studies preferred
- Familiarity with medical device regulations MDD, quality management system (ISO 13485), (21 CFR Part 820), and other medical device-related ISO standards (ISO 14971, ISO 14155)
Please contact Kelvin Pang at +65 6950 0364 or firstname.lastname@example.org for a confidential discussion
EA License no: 16S8066 | Registration no: R1325516
Only successful candidates will be notified.