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Associate Clinical Project Manager

Description

The Associate Clinical Project Manager is responsible for managing operational aspects of global clinical trials. This position will collaborate with cross-functional teams within Global Research & Development to oversee facets of clinical research trials from ideation to publication.

Key Responsibilities include, but are not limited to: 
•    Manage the design and development of clinical trial protocol, identify key deliverables, and publication expectations for single and multi-centered clinical trials. 
•    Ensure clinical trials are conducted in compliance with internationally accepted ethical standards for human research (International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines).
•    Identification, selection, and evaluation of clinical trial site(s) and central laboratory(ies).
•    Oversight of internal and external protocol approval process, including Institutional Review Board (IRB)/Ethics Committee (EC) submission.
•    Track clinical trial progress and effectively communicate progress with project team.
•    Identify clinical trial issues and develop solutions.
•    Collaborate with cross-functional teams to maintain timelines.
•    Develop, negotiate, and manage clinical trial site budgets.
•    Develop and track total project budget actuals against projections.
•    Coordinate data resolution activities.

Qualifications:
•    Bachelor’s degree required, preferably in a scientific field, or equivalent knowledge gained through experience working in a scientific area.
•    At least 2 years of clinical trial experience with extensive knowledge of ICH and GCP guidelines.
•    Understanding of traditional Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) skills (e.g., study planning, execution, data collection, and query resolution).
•    Practical experience of clinical trial methodology, particularly study design and operational aspects.
•    Knowledge of clinical study protocols, case report forms, informed consent, and source documents.
•    Ability to work independently and with a range of technically and culturally diverse people to accomplish project objectives.
•    Familiarity of project management tools and practices.
•    Ability to manage multiple projects at varying stages of completion.
•    Effective in setting and meeting personal short- and long-term goals.
•    Ability to anticipate problems relating to projects and to propose solutions.
•    Excellent communication, organizational skills and attention to detail.
•    Strong MS Office skills.
•    Willing to travel.
•    Experience with clinical trial monitoring and/or electronic data capture is a plus though not required.

US Additional requirements

This role requires relocation to our Evansville, Indiana site (relocation assistance provided for candidates within the U.S.).

Equality

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law. 


Nearest Major Market: Evansville

Job Segment: Clinical Research, Medical Research, Medical Lab, Clinic, Healthcare

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