DescriptionThe
Clinical Trial Manager II is responsible for the operational management and oversight 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 related 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 all levels
- 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 related 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 point of contact for CRAs and Lead CRAs for assigned projects;
- Provides mentoring/oversight of CRAs and Lead 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 source 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)).
RequirementsIDEAL PROFILEEducation - 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 Lead 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 Microsoft Office suite (Word, Excel, Power Point);
- 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 outside of the country once possible;
- Fluent in English (excellent oral and written);
- Experience in a CRO and in dermatology an asset.
Our companyThe work environmentAt Indero, you will work with brilliant 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
