Job Description

Work Schedule Second Shift (Afternoons)
Environmental Conditions Office

• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
• Oversees all department initiatives are implemented to ensure efficiency in proposed processes, consistency in execution and quality output.
• Develops and implements Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs). Develops and implements training processes for staff. Implements project- specific training activities for research staff, including mentoring of new team
• members including other management staff.
• Performs any other duties and projects as assigned by management.

Qualifications:
Education and Experience:
Bachelor's Degree in a life science related field or equivalent and relevant formal academic / vocational qualification.
Significant clinical research experience (comparable to 0 - 5 years) including remote and clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out.
1+ year of leadership responsibility
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:

• Demonstrated ability to attain and maintain a good working knowledge of ICH GCP, applicable regulations and PPD/Client procedural documents for all non-clinical/clinical aspects of project implementation, execution and closeout

• Strong knowledge in all phases of clinical trials, specifically study start-up, study maintenance and study close-out

• Skilled in managing, motivating and mentoring staff

• Ability to analyze and manage clinical administration portion of Business Development bids and contracts for multiple studies within specific division(s)/office(s)

• Knowledge of budgets, projects and metrics

• Ability to handle multiple tasks simultaneously, to meet rigorous timelines and to work effectively in stressful situations

• Excellent organization skills and strong attention to detail

• Excellent communication and interpersonal skills

• Ability to travel if required

Skills Required