Regional Manager, Site Operations - Southeast Region

OBJECTIVE:

The Regional Manager (RM) of Takeda Site Operations is responsible for the functional management of field based Clinical Research Associates (CRAs). The RM is part of a dynamic and innovative team approach that ensures successful protocol level execution of all Site Operations deliverables for Takeda's development projects.



ACCOUNTABILITIES:

Manage up to 15 regionally-based personnel responsible for site identification, qualification, initiation, interim monitoring and study close-out visits for Phase 1-4 studies.

Build and maintain a high performance team of CRAs by recruiting highly qualified candidates. Develop personal training plans for assigned staff and departmental orientation and training programs.

Ensure clinical monitoring activities are conducted according to the monitoring plan and are in accordance with project timelines and company objectives.

Assess risk of issues raised by monitoring staff and understand their potential impact on operational and quality requirements and project timelines.

Review and approve monitoring trip reports. Identify critical issues and bring them to the attention of study management staff.

Review and approve CRA expenditures to achieve cost-effective operations.

Coordinate site selection activities in cooperation with CO study management personnel to ensure potential investigative sites and investigators have had the appropriate evaluation prior to being recommended as a study site.

Assign monitoring responsibilities to field staff, accounting for complexity of site and study issues and travel limitations.

Ensure regulatory inspection readiness at clinical sites in assigned region.
REQUIREMENTS


EDUCATION, EXPERIENCE AND SKILLS:

Education:

Bachelor's Degree required; medical/science/nursing background is preferred

MS, MA, MBA, MPH desired

Experience:

Minimum of seven (7) years of clinical research experience, of which at least two (2) years must be functioning in a lead capacity with mentoring/supervisory/leadership experience, preferably in a field based capacity, and five (5) years in clinical site monitoring

Skills:

Excellent communication and interpersonal skills, including situations of conflict resolution, problem solving and crisis management

Demonstrated ability to effectively train and mentor others with less experience

Demonstrated ability to manage multiple priorities/projects

Demonstrated proactive, positive team player

A good understanding of the drug development process and GCPs

An in-depth knowledge of site monitoring and management processes

TRAVEL REQUIREMENTS:

Requires up to 50% travel.

Submit your resume and start a quality career with Takeda!

 

We are an equal opportunity employer.

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