Real Staffing Group is supporting the recruitment of Clinical Trial Manager for a fast growing, leading innovator in the medical device space.
You will be working in an exciting and fast paced technology startup that values creativity, initiative and passion. The Clinical Trial Manager is responsible for the oversight and management of all clinical operational activities at the trial and site level.
DUTIES AND RESPONSIBILITIES:
- Develops clinical strategy for products in development in coordination with regulatory and marketing strategies.
- Manages vendor and CRO activities, and tracks internal and external 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 Ethics committee document for submission and other tools, templates and documents before clinical site initiation.
- Develops clinical trial timelines, enrolment projections, documents and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans.
- Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations.
- Participates in and leads process improvement activities within the department and cross functionally, including Quality Management System SOP development.
- 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.
- Supports all business segment initiatives as identified by management and in support of Quality Management Systems (QMS) and Regulatory requirements.
- Work closely with a multidisciplinary team to coordinate pilot production of new products and accomplish tasks.
- 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.
QUALIFICATIONS (EDUCATION, EXPERIENCE, SKILLS):
- 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 and other medical device-related ISO standards
If you have the skill-sets and experience needed and looking to propel your career forward, this is an opportunity you cannot miss!
To apply, please get in touch with Grace Tay at g.tay(a)realstaffing.com for further information.
*Please note that only short-listed candidates would be contacted. Thank you.
License No: 16S8216
Real Staffing Group Reg No: 53132073A
SThree Pte Ltd Business Reg No: 200720126E
Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)
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International Recruitment Company of the Year by Recruitment International 2016
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