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Under general direction manage all laboratory aspects of assigned clinical trial projects for a Customer or a specific program for a Customer. May have responsibility for a specific Customer drug program indication or drug compound. Acts as the main point of contact for the Customer after study award and throughout the entire study lifecycle (startup maintenance closeout). Ensures work is conducted in line with standard operating procedures policies and good practices.
Essential Functions
Study Setup and Planning:
Facilitate seamless study setup including Protocol and Budget review leading meetings develop and implement project plans milestone risk issue and action logs. Partner with Study Setup team to ensure quality database setup oversee preparation of protocol specific documentation. Will prepare and present protocolspecific materials at Kick Off and Investigator meetings
May participate in the proposal and business development process including bid defence meetings. Support development of Customer standards
Study Activity Monitoring and Closeout:
Will monitor the Project Management Plan timelines and deliverables manage study documentation throughout the Project lifecycle including filing into eTMF oversee study monitoring and reporting conduct meetings to meet needs of the Study and Customer requirements
Will manage study scope changes and budget monitor quality of the study and any servicerelated issues implementing changes as required. Lessons learnt will be reviewed and shared
Proactive Lines of Communication:
Build and own the Customer relationship facilitate communication collaborate with all operational areas within the company
Will serve as an escalation point for study level issues and will coordinate and triage studyspecific issues
Coordinates customer survey follow up and ongoing health checks to support Customer relationship building
Meetings Initiatives and Training Activities:
Will represent the company at Investigator meetings and other internal / external face to face meetings. Will participate in audits and inspections as required
Will provide study training to sites CRAs and customers
Will establish regular lines of communication with sites to manage ongoing project expectations and issues. Will participate in improvement projects as needed
Will assist in training of less experienced staff.
Qualifications
Bachelors Degree Life Sciences and/or related field Pref Or
Other Equivalent combination of education training and experience may be accepted in lieu of degree.
2 years of clinical or research industry experience including 1 year project management / project set up experience Pref Or
Equivalent combination of education training and experience
Strong interpersonal and customer management skills.
Working understanding of medical and clinical research terminology.
Working knowledge of Project Management processes the company laboratory processes and/or equivalent working knowledge of central laboratory operations (kits/supplies logistics laboratory operations specimen storage data reporting and transfers site alerts etc.) preferred.
Demonstrated computer proficiency with Microsoft Office and the company systems or equivalent experience with similar Centralized Laboratory systems preferred.
Experience in successfully leading Phase IIV clinical trials preferred.
Demonstrated ability to work in a fastpaced environment while possessing strong organizational skills and a demonstrated ability to meet deadlines.
Strong written and verbal communication skills including good command of English language. In certain geographies where communication in local language is desired (e.g. Japan China) excellent command of local language with reasonable proficiency in English preferred.
Ability to establish and maintain effective working relationships with coworkers managers and customers.
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
Required Experience:
Manager
Full-Time