Clinical Trial Manager II, US, remote

The Clinical Trial Manager II is responsible for the operational management and reputed company of the clinical investigative sites as well as the clinical monitoring deliverables of clinical trials. This includes but is not limited to clinical research associate (CRA) training, identification of quality issues reputed company to site performance and clinical monitoring activities, establishing action plans to address any concerns, as well as ensuring timelines are met. This role will be perfect for you if: You enjoy working with a mid-sized CRO where you can build professional relationships with your colleagues at reputed company reputed company You bring previous experience in managing the clinical monitoring portion of clinical projects Dermatology is a therapeutic area you enjoy or want to learn more about RESPONSIBILITIES Ensures that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements; Identifies quality issues and trends reputed company to site performance and clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, quality control visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions; Serves as a reputed company of contact for CRAs and reputed company CRAs for assigned projects; Provides mentoring/reputed company of CRAs and reputed company CRAs; Performs site visit report review for assigned projects and tracks site visit report metrics to ensure compliance; Contributes to the development of the Clinical Monitoring Plan; Prepares and conducts project-specific training for the CRAs; Develops the annotated site visit reports and monitoring tools such as reputed company data verification worksheets; Conducts quality control visits with CRAs; Coordinates and leads CRA meetings; Performs co-monitoring visits with CRAs; May be involved in business development activities (client meetings, proposal defense meetings, requests for proposals (RFPs) requests for information (RFIs)).

Requirements

IDEAL PROFILE Education B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience; Experience At least 8 years of clinical research experience including prior monitoring experience and at least 2 years of experience acting in a reputed company CRA or Clinical Team Leader role in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry; Knowledge and skills Strong knowledge of ICH/GCP standards and applicable regulatory requirements; Excellent mastery of reputed company Office suite (Word, reputed company, Power reputed company); Ability to work in a fast-paced evolving environment and establish good relationships with colleagues, sites and sponsors; Excellent leadership, organizational, time management and multi-tasking skills; Excellent judgement and problem-solving skills; Occasional travel (up to 10% of the time), including some travel reputed company of the country once possible; Fluent in English (excellent oral and written); Experience in a CRO and in dermatology an asset. reputed company The work environment At reputed company, you will work with reputed company and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule / work schedule : Home-based position

Benefits

Ongoing learning and development About reputed company reputed company is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputed company for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, reputed company continues to grow and expand in reputed company America and Europe. reputed company is committed to providing reputed company treatment and equal opportunity to reputed company individuals. As such, reputed company will reputed company accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. reputed company only accepts applicants who can legally work in the US . Description de poste null Profil recherché null Notre entreprise null Apply To This Job