The Clinical Team Manager (CTM) is accountable for achieving successful delivery of clinical activities at the project level by meeting internal and external contractually agreed client and regulatory requirements according to time, quality/scope and budget constraints. The CTM leads and directs cross functional teams (Clinical Operations, Regulatory Affairs) and understands/manages client expectations. The CTM proactively identifies, resolves/mitigates and escalates risks and/or issues. Depending on the business unit the descripted ccountabilities may or may not apply.
Applies knowledge of PRA’s policies and procedures
Manages international clinical teams and multiple trial deliverables
Demonstrates excellent written and oral communication with internal/external teams and with the customer
Reads, writes and speak fluent English; and is fluent in host country language
Demonstrates excellent knowledge of ICH/GCP
Utilizes clinical knowledge to develop and implement task and trial specific training
Accurately projects work and resourcing requirements
Interactions with multi-functional teams and with the sponsor
Contributes to the preparation and presentation of bid defenses
Understands associated functions as they relates to Clinical/Trial Management
Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, and Electronic Data Capture platforms
3+ years of clinical research experience required
Read, write and speak fluent English; fluent in host country language required.
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.
2+ years monitoring experience preferred
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.