Project Manager Clinical Affairs - Spring Professional
Posted on Apr 17, 2019 by Spring Professional
Responsibilities:• 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 relevant regulatory requirements (e.g. ISO 14155).
• Develop and deliver technical training on GCPs, and relevant regulatory requirements (e.g. ISO 14155),, 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 site management including Institutional Review Boards, Contract, and Training, and developing process improvements.
• Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
• Act as a mentor to new or junior level employees.
• 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
Profile:• Bachelor's Degree or equivalent in related field
• 5 years of previous experience (monitoring a clinical trial)
• Excellent written and verbal communication skills and interpersonal relationship skills
• Strong problem-solving and critical thinking skills
• Good ability to read and write English preferred
• Full understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
• Full understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations