Hobson Prior are seeking a Project Manager (Clinical Affairs) medical devices company who specialise within artificial heart valves and hemodynamic monitoring. This position will be responsible to ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.
- 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.
- Develop and deliver technical training on GCPs, and relevant regulatory requirements, 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.
- Deliver oversight of and insights into trial activities 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.
- Represent as a mentor to new or junior level employees.
- Participate in 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 from Edwards to the field sites and through final disposition.
- Excellent written and verbal communication skills and interpersonal relationship skills.
- Strong problem-solving and critical thinking skills.
- Advanced problem-solving skills.
- Ability to manage confidential information with discretion.
- Strict attention to detail.
- Ability to interact professionally with all organizational levels.
- Bachelor's Degree or equivalent in related field.
- 5 years of previous experience (monitoring a clinical trial).
- Full knowledge and understanding of company’s policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies.
- 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.
- Adhere to all company rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
- Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g. iMedidata).
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.