When our values align, there's no limit to what we can achieve.
This role is ideal for IRT or eCOA professionals with proven experience in clinical trials.
Picture Yourself At Parexel:
The Vendor Systems Project Manager provides tactical management and leadership to ensure vendor systems projects proceeds on time, within budget and with quality, delivering to appropriate industry and regulatory standards therefore maintaining and enhancing client satisfaction.
This individual serves as the primary operational interface between the vendor team, Parexel project team and functional teams. This role oversees program management and manages key account relationships for vendor systems.
They are responsible for the oversight of initial builds and updates to the system design, creating and managing timelines, deliverables, milestones, and financials relating to vendor systems during the life of the study.
The Vendor Systems Project Manager provides guidance, leadership, and mentorship to Design Consultants and UAT leads.
What You'll Do At Parexel:
1. Oversees delivery of vendor system builds and system updates within budget, timelines and quality
2. Manages resourcing requests to Parexel functional teams and ensures appropriate resources are assigned to study work in good time
3. Collaborates with client, vendor, Parexel project teams and functional teams to create and manage timelines for delivery of vendor system builds and updates.
4. Maintain good financial management practices to ensure project profitability and capturing of revenue
5. Actively identifies and documents all potential changes to the clinical systems on an assigned study
6. Lead delivery of vendor system changes
7. Identifies inefficiencies with current processes and leads process improvements
8. Utilize delegation and negotiation skills with regards to project tasks, to obtain maximum productivity and team involvement
9. Responsible for successful completion of project deliverables
10. Responsible for resolving study issues in a timely, proactive and effective manner
11. Ensure compliance with SOPs and other relevant regulatory body directives e.g. 21 CFR Part 11, ICH-GCP
12. May support pre-sales process
13. Assesses and documents all project risks for potential changes to clinical systems
14. Ensures any identified risks are mitigated seeking appropriate input from all stakeholders, maintaining accurate documentation, and communicating to internal and external parties as appropriate
15. Primary client contact for the vendor systems on the study, manages the client relationship
16. May be involved in program management and/or key account relationship management
17. Manages and lead complex programs of work
18. Communicates regularly and effectively with internal and external team members regarding delivery status and provides timely notification to all appropriate parties with deviations from timelines and/or deliverables
19. Act as vendor system Lead in sponsor & vendor meetings
20. Oversee quality review
21. Review and approve validation documents
22. Accountable for the documentation quality
23. Accountable of the documentation filing in the eTMF
24. Leads quality investigations to successful conclusion and within appropriate timeframe
Who we’re looking for:
25. Proven IRT/RTSM and/or eCOA / ePRO expertise is required
26. Deep knowledge and proven experience in clinical trials / pharmaceutical environment is required
27. Extensive system set up delivery experience
28. Experience of leading and delivering complex projects within a matrix organisation
29. Proven track record of developing client relationships at project level
30. Proven leadership qualities and advanced project management experience
31. Strong interpersonal, verbal, and written communication skills
32. Ability to build relationships and interface effectively with external clients, vendors and internal employees
33. Negotiation, influencing, and organizational skills
34. Ability to foster teamwork and drive toward achievement of goals
35. Strong problem solving, prioritization, and decision-making skills
36. Fluent English
37. Bachelor's degree as a minimum