Project Manager Assistant - Sponsor Dedicated

Job Overview
Associate Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Associate Project Lead is a member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices. Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. The Associate Project Lead support the efforts of CPM to drive operational excellence and strategic leadership with our customers. Associate Project Leads may run their own studies, as part of their development.

Essential Functions
• Serves as direct link to PMSO CTC for supporting study finance coordination.  Will review and approve (as coordinated with CTL) study invoices. 
• Collating of Vendor data from study team and Tracking of Vendors (including 3rd party vendors) into CML
• Customizes Inspection Readiness Tool, schedules & attends IR meetings.  Supports the completion of IR tool and follows up with study team to ensure any identified actions are closed.
• Serves to coordinate KOM (initial and All-Hands KOM) with agenda preparation, schedule & attend KOM, and prepare meeting minutes.  Will follow up with team members to ensure any identified actions are closed.
• Prepare ISMP draft and circulate/file finalized version. Conduct regular review and coordinate with study team to ensure plans within ISMP are up to date

• Support trial team timeline discussions using Accelerator Tool

• Serves to assist with coordination of Inv Meeting with agenda preparation, schedule & attend INV, and prepare meeting minutes.  Will follow up with team members to ensure any identified actions are closed.
• Will liaise with vendor to support the creation and internal approvals of study related materials (i.e. brochures, diaries, emergency cards)
• Customizes TOP Tool, schedules & attends TOP meetings.  Supports the completion of TOP tool and follows up with study team to ensure any identified actions are closed.
• Supports collection and filing of required training and team handover documents
• Create and maintain trial team list in/outside of CML

• CML CTMS data entry, quality checks and overall maintenance of study fields.  Will review discrepancy report on behalf of CTL to resolve.
• Creation of study team TEAMS space and CTM WF with template folders
• Serves as CES study team representative/ coordinator of related topics such as eTMF status & metrics, PO/invoice updates, etc.  Will present at team meetings as required.

• Will have access to WINGSPAN eTMF, Clinical Analytics, CML CTMS, Veeva Vault RIM Breeze, Spotfire Dashboard for any checks/report generation as necessary. 

Qualifications
• Associate's Degree In life sciences or related field required Req Or
• Bachelor's Degree In life sciences or related field required Req
• 2 years clinical research experience. Req
• Requires intermediate level knowledge of principles, theories, and concepts of a job area, 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.;
• Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.
• Problem solving - Strong problem solving skills.
• 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.
• 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.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com