Study Start-Up Manager (Home- Based) - IQVIA Biotech
Descripción del trabajo
IQVIA Biotech is now hiring a Study Start-Up Managers with Global experience.
The SSU Manager is responsible for providing customer-focused leadership in the execution of operational strategy and management of start-up activities for projects or programs. This includes but not limited to the overall management and oversight of the following processes: site feasibility, regulatory approvals, and site contracts. May be assigned to manage the site start-up activities for a country, region, or global trial.
The SSU Manager also has responsibility for maintaining internal tracking for study site status from initial site contact through site initiation and maintains clear client and internal team communication and documentation. This position works directly with Clinical Monitoring, Project Management and Clinical Trial Managers in setting priorities and expectations for study start-up.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Serve as SSU Manager within regionally or globally for project(s) or programs or service line. Lead SSU team or service line in all activities during start-up phase. Monitor team efficiency, quality and adherence to project timelines, budget, SOPs and WPs.
- Develops, with the input of regulatory and contracts, a study specific SSU plan.
- Communicates overall site activation status to internal teams and sponsor.
- Directs the process for the selection of study sites and investigators. Attend project meetings with cross functional department leads to provide strategy for identifying potential investigators.
- Works with sponsors and internal team members to establish regulatory requirements and contracts necessary for start-up.
- Where applicable, provide work instructions to team members in preparation of regulatory submissions.
- Establishes processes for the collection and initial review of regulatory packets and site contracts for investigator sites.
- Facilitates communication with the clinical team (e.g. SSU Specialist, Project Managers, Clinical, Regulatory Affairs, Vendors, and Contracts Department) during site start up, closely monitoring to ensure site activation timelines are met.
- Works with SSU Leadership team to implement QC/QA processes that are effective in providing high quality deliverables to our internal and external teams.
- Directs the development of study start up Review plans. Assures team members incorporate required elements of the Regulatory Plan and Monitoring Plan in accordance with Good Clinical Practices (GCP). Works with SSU Leadership Team to implement processes that assures compliance.
- Works with SSU Leadership Team to design, develop, and update Standard Operating Procedures & WP’s for all SSU functions.
- Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
- Review and provide feedback to management on site performance metrics.
- Developing appropriate early warning systems of potential obstacles to the successful completion of study start-up; analyzes information and develops innovative solutions to challenges
- Responsible for escalation of issues and reporting progress to study teams and clinical management weekly, including plans for addressing/mitigating risks/gaps.
- Reviews and approves reports and manuscripts, as necessary.
- Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.
- Participates in business development activities (e.g. BD content, prep, presentation and/or face to face attendance) to grow IQIVA Biotech’s business.
- Participates in study financial forecasting for SSU activities.
- Facilitate process improvement efforts both within the department and in cooperation with other departments.
- Provide oversight and mentorship to other staff
KNOWLEDGE, SKILLS & ABILTIES:
- Demonstrated ability to manage a team of people around clinical research related activities.
- Demonstrated knowledge of quality assurance related to study start-up.
- Demonstrated ability to form strong working relationships across functional boundaries.
- Demonstrated ability to motivate, lead, and grow a study start up team.
- Excellent written and verbal communication skills.
- Exceptional ability to conceptualize, develop and manage timelines.
- Ability to delegate.
- Ability to manage multiple projects and priorities.
- Ability to set baseline targets, track trends and implement mitigation plans.
- Demonstrated knowledge of resources required to permit protocol implementation.
- Considerable ability to develop and maintain productive relationships with coworkers, managers and clients.
- Ability and willingness to travel. May include international travel.
- Working knowledge of current clinical trial regulations.
- Knowledge of electronic data management and issues affecting study start up.
- Ability to work independently, prioritize and work with in a matrix team environment is essential.
- Working knowledge of Word, Excel, and PowerPoint required.
- Limited travel may be required
- Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
- BS /BA/BSc or equivalent in a health-related field plus 7 years of related clinical trials experience
- within the total years of experience, at least 2-3 years of project lead experience is required
- Equivalent combination of education, training and experience
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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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