Senior Study Start-Up Manager, Home-Based - IQVIA Biotech

Location: Mississauga, ON
Job Type: Full Time
Posted: 69 days ago
Company: IQVIA Holdings Inc
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BASIC FUNCTIONS: The Senior 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 acting in the following positions: Senior Study Start-Up Manager 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. Study Start-Up Delivery Manager Responsible for the oversight of Study Start Up (SSU) delivery.

Provide oversight to the assigned projects ensuring activities are in line with contracted scope; monitor the resourcing requirements of assigned studies; review financial reports to track execution towards proposed budget; and support the efforts of SSU Team Members, ensuring clear client and internal team communication. Oversees the team to ensure country and site level process documentation is in compliance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients. Provide mentorship to SSU team members, providing support to identify and mitigate risks to EDP projections that may arise during SSU.

Support and coach the SSU team through project level problem solving. 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 (eg, 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 (eg, 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 Reviews and provides input to department SOPs/WPs. Provide oversight and mentorship to other staff. May have line management responsibilities of other SSU staff In addition to the above, the Service Delivery Manager may also:.

Provides SSU study oversight responsibilities and develops strategies to support the team to deliver execution of study timelines, corporate and department quality metrics, resource management, performance oversight, and team collaboration activities Support Study escalation, providing SSU strategy and focused support to mitigate risks and re-projections as needed Communicates challenges and concerns to Study Start Up Line and Department Management, as well ensures site-level and country-level related study tracking is quality checked on a regular basis and maintained to departmental standards and IQVIA Biotech SOP/WPs Maintains contact, as needed, with Project Managers, Clinical Trial Managers and other functional study leads to ensure overall service delivery of the project Ensures the assigned SSU Team is maintaining Study Management Plans, eg, SSUP and FRP are aligned for SSU expectations. Participates in financial and/or resource forecasting; ensures financial deep dives are completed on studies and out of scope activities are alerted to Management, PM, and study team to ensure that such activities do not begin until authorization by PM and Management has been provided Provides support to SSU team regarding budgets for assigned studies and ensures accountability when additional activities may cause budget overburn. Ensures SSU teams are identifying, documenting, and raising changes in scope for SSU activities to the PM and financial forecasting is accurate.

May support SSU team as SME for budget and financial forecasting Liaises with Department Quality Manager to support SSU Quality Issues and escalates as needed Identifies ongoing quality concerns and areas for improvement with SSU Line and Department Management. Identifies areas of process improvements and coordinates with SSU global management team to resolve issues; includes supporting process development, strategizing study management improvements and updates to trainings and/or SOP/WP Collaborates with line management when staff performance issues are identified on a study and provides support to line management to resolve the staff level issues Supports the SSU team with interactions with the Sponsor, attending meetings if required. Serves as IQVIA Biotech representative in interactions with the sponsor, when required.

Serves as a team trainer and mentor as new projects are awarded. 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 Ability to provide oversight and mentorship to other staff. Knowledge of electronic data management and issues affecting study start up Ability to work independently, prioritize and work within a matrix team environment is essential Working knowledge of Word, Excel, and PowerPoint required. PHYSICAL REQUIREMENTS:. 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 8-9 years of related clinical trials experience. within the total years of experience, at least 3-4 years of project lead experience is required.

supervisory experience preferred. Equivalent combination of education, training and experienceIQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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.

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