Indero

Indero, formerly known as Innovaderm, is a Canadian research institute specializing in dermatology and rheumatology, positioning itself as a clinical trial delivery partner for imm

Clinical Trial Manager II

Location

Argentina

Posted

80 days ago

Salary

0

Seniority

Lead

No structured requirement data.

Job Description

Clinical Trial Manager II

Indero

Role Description The Clinical Trial Manager II (CTM II), Dermatology & Rheumatology, 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 - 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 and rheumatology are therapeutic areas 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)) Qualifications - B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent 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 - 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 Benefits - Flexible work schedule / work schedule - Home-based position - Ongoing learning and development Company Description Indero is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Argentina.

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United States
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Samsung HME America Inc logo

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United States
Johnson & Johnson logo

Clinical Research Manager

Johnson & Johnson

Johnson & Johnson is an award-winning, family-owned-and-operated company that has been providing health and wellness products for more than 120 years. Employing

Title: Clinical Research Manager Location: Irvine, California, United States of America Job Description: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders; - Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures; - Should develop a strong understanding of the pipeline, product portfolio and business needs; - Manages work independently. 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Create strong and productive partnership with resource providers and vendors. - Shape - Make recommendations for and actively participate and lead in departmental process improvement activities. Through efficient use of resources, shape the way clinical trial management is conducted and resources are utilized. - Lead - Continually develop expertise to provide strategic and scientific clinical research capability. Ensure appropriate escalation of compliance issues. - Deliver - Ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance to SOPs and regulations. Ensure all sponsored studies have appropriately trained clinical trial leaders/ specialists assigned. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource. #LI-Hybrid Required Skills: Preferred Skills: Clinical Data Management, Clinical Evaluations, Consulting, Developing Others, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Operational Excellence, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Team Management The anticipated base pay range for this position is : $117,000.00 - $201,250.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). 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