Senior Clinical Study Manager

Job description

Job responsibilities

• Accountable for leading assigned clinical research activities
• Partner with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocol and study outlines and subsequently driving identified initiatives
• Accountable for the planning and execution of the clinical studies including site selection, review of potential patient recruitment and projections, creation of study related documents (protocols, case report forms,…
• Accountable for autonomously conducting clinical studies on schedule and within budget while ensuring high quality and compliance
• Oversee 3rd parties and/or clinical research organizations (CROs), as applicable
• Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits.
• Conduct clinical study monitoring and/or oversee CRAs to ensure regulatory and protocol compliance as well as overall data accuracy in accordance with the study clinical monitoring plan
• Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a case report form at sites or in data listings to ensure regulatory and protocol compliance and overall…

Job requirements

• Previous experience managing and implementing pre-market medical device trials. Significant knowledge of clinical and/or outcomes research study design
• Proven experience in protocol and ICF development, writing clinical section(s) for regulatory submission
• Proven experience in conducting literature searches, reviews and appraisal of the scientific data
• Excellent ability to interact with physicians and other professionals inside and outside the company
• Knowledge of Good Clinical Practice ICH/GCP, FDA regulations, and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
• Experience negotiating clinical research contracts and budgets
• Must be able to work effectively on cross-functional teams
• Must be able to travel 25-40% or based on business requirements