Clinical Trials Monitoring Manager (US Pharma MNC, Regional, Global Study Mgmt)
Design, plan and conduct clinical research trials by effectively coordinating the activities of study coordinators and investigators and by ensuring compliance with study protocols, FDA and International regulations, IRB and/or Ethics committees requirements and overall clinical objectives.
• Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
• Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities.
• Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements.
• Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects.
• Validate investigational device accountability by tracking the history of investigational devices to the field sites and through final disposition.
• Bachelor’s degree in Life Sciences or related field is highly preferred. Associates or equivalent 5-10 year clinical degree in Life Sciences or related field or equivalent in work experience is required. GCP/ Clinical research certification is strongly preferred (ACRP or SoCRA, Clinical Coordinator/CRA certification).
• Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are a must.
• Knowledge of FDA regulatory requirements related to the conduct of clinical studies.
• Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
• Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
If you are interested in the position, do kindly drop your most updated resume to [Click Here to Email Your Resume] (Attn: Clinical Trials Monitoring - Leon)
Leon Leong De Cong
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
Recruit Express Pte Ltd