The SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning,executing, and reporting, (from first site initiation visit to and including study site close-out), of assigned studies in compliance with Sponsor processes and regulatory requirements.
The CPM is the single point of contact and study team lead, in the country/cluster/hub, for the assigned studies. The CPM is responsible for assuring aligned communication with Trial Leads and other CTT members, locally with Clinical Research Associates (CRAs), CRA Managers and other key associates on the execution and progress of their studies. The CPM collaborates with the SSO Country Manager, SSO Country Head, SSO Feasibility Manager, SSO Study Start-up Manager and SSO Site Partnership Manager in the planning, execution, and delivery of their assigned studies. Accountable for execution and reporting of assigned studies in E2E product line Clinical Operations Program Head/Study Lead/CPM – CRA. Can be assigned partially to participate in the review process of Site Monitoring Plans across the Portfolio.
Responsabilities:
1. Supports SSO Study Start-up Manager with the development of country/cluster/hub study execution plans and timeline commitments.
2. Participates with the recruitment sub-team and supports the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time
3. Proactively identifies risks and opportunities for the assigned studies in the country/cluster/hub and develops respective mitigation plans
4. Supports study feasibility as requested by the SSO Feasibility Manager by providing input to the study protocol and operational aspects of the study
5. Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites and Country/Cluster/Hub personnel
6. Drives the conduct of the study (tracks status, maintains relevant reporting systems, oversees forecasts, progress, and mitigation plans) to ensure all study operational aspects are on track
7. Ensures recruitment targets are met and reviews enrollment at the site level including responsibility for obtaining approval from the STUDY LEADER on enrolling above site targets.
8. Responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
9. Oversees local study team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Sponsor standards and relevant regulations
10. Leads/chairs country/cluster/hub study team meetings, participates in global clinical trial team meetings, as required, and is the single point of contact for the conduct of assigned studies
11. Maintains oversight of country/cluster/hub level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues
12. Coordinates the study handover process with CRAs and their managers to ensure proper documentation and communication, when necessary
13. Tracks all study close–out activities and ensures they are performed in a timely manner, in collaboration with CRAs and key study stakeholders
14. Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
15. Conducts or coordinates local investigator meetings, as needed, and ensures relevant training documentation is archived in the Trial Master File
16. Evaluates potential challenges/risks in the protocol and operational aspects of the study; assesses impacts, develops risk management plans, and communicates/escalates to global teams and SSO Hub Head Portfolio, as appropriate
17. Accountable for monitoring quality and issue resolution through timely review and approval of study monitoring visit reports to ensure quality trial oversight and appropriate issue escalation
18. Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times.
19. Acts as the escalation point for issues in monitoring visit reports (MVRs) for the assigned studies.
20. Responsible for evaluating trends identified in MVRs and communicating/escalating these to global teams, as appropriate. Communicates with CRAs and their managers to ensure issue resolution in a timely manner
21. Provides feedback about the quality of monitoring activities to CRA Managers, MSOM, SSO Country Managers, FSP/BiS line managers, as appropriate, and to local QA (when required per Sponsor SOPs)
22. Supports inspection readiness and submission preparation for monitoring-related activities; assists and coordinates with country Portfolio Execution and Quality Assurance for internal audits organization and HA inspections, as required, and ensures implementation of corrective actions within specified timelines.
23. Monitors the status of site budget and contract negotiations as well as the collection and review of essential documents throughout study conduct.
24. Tracks study budget with appropriate study budget in responsible Country. Ensures timely TCF preparation and submission.
25. Processes invoiceable items for site level clinical study activities to allow timely payments
26. Serves as core member of the Global Clinical Trial team as a Country and Hub representative responsible for all local level feedback to the global trial execution teams.
27. Interfaces with SSU teams to ensure on-time initiation of all sites within geography.
28. Interfaces with Country study execution teams, including CRAs and CRA Managers, to ensure on-time recruitment, data delivery, and study close out.
Requirements:
achelor's Degree Life sciences or related field Req
• 5 years of prior relevant experience including > 1 years project management experience or equivalent combination of education, training and experience. Req
• Advanced knowledge of job area, and broad knowledge of other related job areas, typically obtained through advanced education combined with experience. Req
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge; therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.;
• Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.
• Problem solving - Strong problem solving skills.
• Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.
• Leadership - Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
• Organisation - Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
• Prioritisation - Ability to handle conflicting priorities.
• Quality - Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.
• Quality - Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
• IT skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
• Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong customer service skills.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
• Finances - Good understanding of project financials including experience managing, contractual obligations and implications.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).
*Please note This role is not eligible for UK visa sponsorship
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