Vendor Systems Project Manager – RTSM / IRT / eCOA
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Job Description
Vendor Systems Project Manager at Parexel managing IRT/eCOA systems for clinical trials. Overseeing project deliverables, client communication, and quality management in a remote setting.
Responsibilities:
- 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
- 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
- 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
- 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
Requirements:
- Proven IRT/RTSM and/or eCOA / ePRO expertise is required
- Deep knowledge and proven experience in clinical trials / pharmaceutical environment is required
- Extensive system set up delivery experience
- Experience of leading and delivering complex projects within a matrix organisation
- Proven track record of developing client relationships at project level
- Proven leadership qualities and advanced project management experience
- 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
Benefits:
- Health insurance
- 401(k) matching
- Paid time off
- Flexible work arrangements
- Professional development opportunities
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