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:
Project Planning & Execution
* Oversees delivery of vendor system builds and system updates within budget, timelines and quality
* Manages resourcing requests to Parexel functional teams and ensures appropriate resources are assigned to study work in good time
* Collaborates with client, vendor, Parexel project teams and functional teams to create and manage timelines for delivery of vendor system builds and updates.
* Maintain good financial management practices to ensure project profitability and capturing of revenue
* Actively identifies and documents all potential changes to the clinical systems on an assigned study
* Lead delivery of vendor system changes
* Identifies inefficiencies with current processes and leads process improvements
* Utilize delegation and negotiation skills with regards to project tasks, to obtain maximum productivity and team involvement
* Responsible for successful completion of project deliverables
* Responsible for resolving study issues in a timely, proactive and effective manner
* Ensure compliance with SOPs and other relevant regulatory body directives e.g. 21 CFR Part 11, ICH-GCP
* May support pre-sales process
Risk Management
* Assesses and documents all project risks for potential changes to clinical systems
* Ensures any identified risks are mitigated seeking appropriate input from all stakeholders, maintaining accurate documentation, and communicating to internal and external parties as appropriate
Client & Vendor Communication
* Primary client contact for the vendor systems on the study, manages the client relationship
* May be involved in program management and/or key account relationship management
* Manages and lead complex programs of work
* 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
* Act as vendor system Lead in sponsor & vendor meetings
Quality Management
* Oversee quality review
* Review and approve validation documents
* Accountable for the documentation quality
* Accountable of the documentation filing in the eTMF
* Leads quality investigations to successful conclusion and within appropriate timeframe
Who we're looking for:
* IRT/RTSM and/or eCOA / ePRO Expertise is required
* Deep knowledge and proven experience in clinical trials / pharmaceutical environment is required
* Extensive project management experience within system set up delivery
* Experience of leading and delivering complex projects within a matrix organisation
* Proven leadership qualities and advanced project management experience
* Proven track record of developing client relationships at project level
* Strong interpersonal, verbal, and written communication skills
* Ability to build relationships and interface effectively with external clients, vendors and internal employees
* Negotiation, influencing, and organizational skills
* Ability to foster teamwork and drive toward achievement of goals
* Strong problem solving, prioritization, and decision-making skills
* Fluent English
* Bachelor's degree as a minimum
A little about us:
Highly qualified and dynamic team. Multinational working environment. Smooth induction and training program. We offer competitive financial packages, training, and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.
Parexel has a fully flexible work arrangement - you can be fully home based. But if you live close to our office and you want to use it, you are always welcome, and we will keep the desk ready for you
We are unable to sponsor or take over sponsorship of an employment Visa.