Assoc Lab Project Set-Up Mgr

Job Overview
Manage the process of designing and launching clinical research studies; manage activities of the Sponsor/Clinical Research Organization (CRO); lead colleagues in the design and organization of project components during Start-Up; develop and maintain best practices within the organization; Accountability and ownership for the quality of all start-up work and sponsor deliverables.

Essential Functions
Develop the database design requirements which include configuration definition for full protocols protocol amendments and sponsor study changes
developing and maintaining client design standards as applicable in accordance with the Clinical Protocol
Manage study database configuration. Support internal/external stakeholders in the development of sponsor standards and as a Set-up point of contact
Collaborate with colleagues during planning meetings regarding project timelines and project-related issues focusing on capabilities within but not limited to Data Management Logistics Clinical Trial Materials Laboratory Testing and Specimen Management
Responsible for updates to the project including the action/issues logs status sheets and timelines during the startup phase where applicable
Communicate and coordinate set-up activities with clients and internal customers to ensure that all milestones are achieved
Proactively manage changes in study related project scope identify potential risks and devise contingency plans
As required prepare and present study-specific materials and services at Investigator Kick-off meetings. Participate in external and internal audits as required
Provide day to day guidance to more junior staff assigned to project or within a specific program area
may act as a mentor as well as assist in the training and development of more junior staff
Participate in improvement projects as defined by the relevant process improvement management team. Conduct project lesson learn sessions and create a recommendations report in order to identify successful and unsuccessful project elements when applicable
Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

Qualifications
Bachelors Degree Science or related field Pref
Other Equivalent combination of education training and experience may be accepted in lieu of degree. Req
Minimum 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 Req
Possess strong interpersonal skills.
Demonstrated ability to meet deadlines.
Some experience in leading Phase I-IV clinical trials would be advantageous. Some technical and therapeutic expertise would be advantageous in addition to significant experience with key customers.
Demonstrated computer proficiency with Microsoft Office. Working knowledge of Clinical Trials Management Systems would be an advantage.
Possess an understanding of medical and clinical research terminology.
Demonstrated ability to work in a fast-paced environment.
Knowledge of Project Management processes and terminology.
Excellent organizational and time management skills.
Excellent accuracy and attention to detail skills.
Ability to establish and maintain effective working relationships with coworkers managers and clients.

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