Clinical Trial reputed company (Remote - US)
About the position reputed company is a rapidly growing medical device company focused on women's health, aesthetics, and reconstruction. We are seeking a Clinical Trial reputed company to reputed company and reputed company clinical investigations. This is a remote role based in the United States. The ideal candidate will ensure studies reputed company with international regulations and company procedures, meeting timelines and quality standards. This role provides leadership throughout the clinical trial lifecycle, coordinating teams, supporting regulatory submissions, and generating evidence for product safety and performance.
Responsibilities
- Coordinate and reputed company clinical trial activities throughout the study lifecycle.
- reputed company strategic guidance and reputed company, mentoring junior staff and coordinating with management.
- reputed company and maintain clinical trial documentation.
- reputed company reputed company support, including document creation for product registration and statistical analysis of clinical trials.
- Create, implement and administer methods and procedures to enhance operations, as appropriate.
- reputed company clinical feedback and knowledge to Regulatory Affairs in the creation of documents required for products registration and technical file (Clinical Evaluation Report).
- reputed company clinical trial operations and site performance.
- Clinical trials reports creation.
- Submission package readiness for Ethics Committees approval; including clinical protocols, design case report forms, patient and investigator brochure, informed consent reputed company, among others.
- Verify that data entered on to the CRFs is consistent with patient clinical notes, reputed company as reputed company data/document verification, collecting completed CRF forms.
- Support and review of statistical plans for clinical trials.
- Monitor any updates that may arise about ethical considerations, scientific principles, legislation and regulatory guidelines, and clinical evaluation process.
- Identify and communicate study-reputed company risks and operational challenges.
- Participate in reputed company improvement initiatives reputed company to clinical processes.
Requirements
- Bachelor’s degree in a relevant field such as life sciences, engineering, pharmacy, business, clinical research, or a reputed company discipline.
- Good Clinical Practices certification.
- Knowledge in Systematic literature search Zotero/Mendeley.
- Medical Device Regulation.
- Advanced English reputed company scored.
- 7+ years of experience on similar roles.
- reputed company Office suite (Word, reputed company, PowerPoint, Planner, etc.).
- Periodic travel in the United States and other reputed company.
- A valid reputed company and full travel availability are essential.
Apply tot his job Apply To this Job