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Clinical Study Manager (CSM)

Iqvia

This is a Full-time position in Houston, TX posted April 21, 2021.

**Join as a Clinical Study Manager, an integral part of IQVIA’s clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster.

IQVIA’s CSMs are members of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices.

Clinical Study Managers are focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction.****
• Recognize potential challenge within the protocol and operational aspects of the trial and escalate to manager as appropriate.****
• Maintain a strong knowledge of the protocol to be able to answer standard operational questions from monitors, sites, and local internal personnel.****
• In liaison with the global clinical team, assist in the development of local trial execution plan and timeline commitments for a country/cluster.****
• Ensure that study start-up activities and any amendments are conducted and completed on time, including preparation of IRB/EC submission packages, working with regulatory affairs for Health Authorities submissions.****
• Monitor the status of site budget and contract negotiations as well as the collection and review of essential documents.****
• Ensure sites are prepared for “Ready to Initiate Site” (checkpoint).

Obtain written confirmation about availability of global documents.****
• Ensure that all documentation in place for initial and subsequent drug release in collaboration with the local Qualified Person.****
• Provide training as needed for monitors and any other activities that support site readiness to recruit.****
• Ensure documentation of training** **(global/regional/local** **IM minutes, participants’ lists, certificates, etc.) is archived appropriately.****
• Drive the conduct of the trial, track and oversee progress and status.****
• Ensure all operational aspects are on schedule.****
• Oversee local clinical team activities to achieve trial timelines and quality execution according to Novartis standards and local and international regulations.****
• Consistently read/review the content of all monitoring visit reports for the assigned trial to identify trends and issues.

Appropriately escalate issues in a timely manner and ensure resolution.****
• Communicate with field monitors on a regular basis to assure proper adherence to protocol, timelines andother trial related topics.****
• Lead and chair local study team meetings, attend and participate in global clinical trial team meetings.****
• Track trial budget with appropriate trial budget responsible in country.

Oversee TCF preparation and submission to COM in collaboration with the TCF specialist in the country.****
• Keep oversight of country level data management activities, including timely resolution of data entry issues, screen failure reasons, discontinuation rates, patient profiles, and proactively identify data entry issues to mitigate queries.****
• Accountable to keep reporting systems up to date: ClinAdmin, TMF, CREDI…

throughout trial conduct****
• Ensure that all trial closeout activities are performed, in close cooperation with field monitors and clinical trial head.****
• Oversee local vendor selection and performance as needed.

Serve as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required****
• Facilitate internal audits and HA inspections as required.****
• Support trial feasibility and CPO patient commitments in cooperation with the relevant line units: ensure two-way feedback on feasibility between global team and country.****
• Coordinate and manage the site selection process in collaboration with the necessary line units.****
• Conduct local investigator meetings as needed****REQUIRED KNOWLEDGE, SKILLS AND ABILITIES****Good knowledge of Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines****Proven ability to work through others to deliver results to the appropriate quality and timeline metrics****Proven ability to understand customer needs and appropriately influence decision making****Effective mentoring and training skills****Ability to balance operational and strategic priorities****Strong communication and interpersonal skills, including good command of English language****Effective presentation skills****Demonstrated proficiency in using systems and technology to achieve work objectives****Demonstrated proficiency at analyzing data and information to make conclusions and drive sound decision making****MINIMUM REQUIRED EDUCATION AND EXPERIENCE****Bachelor’s degree in a health care or other scientific discipline with 5 years clinical research/monitoring experience; or equivalent combination of education, training and experience.****PHYSICAL REQUIREMENTS****Extensive use of telephone and face-to-face communication requiring accurate perception of speech****Extensive use of keyboard requiring repetitive motion of fingers****Regular sitting for extended periods of time****Occasional travel requirement**At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible
– to help our customers create a healthier world.

The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.

Learn more at jobs.iqvia.com .IQVIA is an EEO Employer
– Minorities/Females/Protected Veterans/DisabledIQVIA, Inc.

provides reasonable accommodations for applicants with disabilities.

Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare
– and human health
– forward.

Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.To get there, it takes diverse skills and a curiosity to explore new possibilities.

No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health.

Thank you for your interest in growing your career with us.

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