Covance Senior Manager, Project Integration in Tokyo, Japan

Job Description:

• A member of the leadership within the global Project Integration team with a particular focus on project management and signature client service delivery for projects with a CDARO component. • Responsibility for all aspects of administration, organization of the department, and has responsibility for the professional and personal development for all individuals within Project Integration. • Ensure all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical Practices. • Performs supervisory duties including but not limited to interviewing, hiring, training, intervention, discipline, and discharging of staff. • Coaches and mentors staff including initiating and implementing appropriate staff development programs. Meets with staff on a routine basis to review goals and individual development plans. • Motivates team to complete high quality work efficiently. • Schedules team workflow. Ensures that staff levels are adequate to meet the forecasted workload. Recommends changes if necessary and justifies them in accordance with company policy. • Ensures that appropriate training programs are in place so that staff is adequately and properly trained for their job requirements. • Ensures that all training files are up to date and complete in accordance with SOPs and ICH/GCP. • Assists in the review and amendment of departmental processes and supporting documentation. • Ensure that the highest levels of client service are maintained. • Serves as a Project Manager on assigned studies. • Identify specific Project Integration requirements from clients. • Coordinate Data Management, Programming, and Statistics projects, teams, and deadlines. • Communicate on a regular basis with assigned clients regarding questions, concerns, and project status. • Organize, chair, and record minutes for all project team meetings. • Facilitate meetings with Sponsors. • Ensure the relevant personnel are kept informed of problems that may affect the project performance. • Ensure all appropriate documentation and procedures are performed upon project completion. • Communicate with the Data Management, Programming, Statistics, Pharmacokinetics, Medical Writing, and QA departments regarding study progress and reporting requirements. • Update the Project Integration internal timelines for allocated projects in a timely manner. Renegotiate timelines as appropriate. • Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team. • Provide senior management with updates on timelines and projects. • Keep senior management and/or client services informed of pertinent project or client related information (i.e., work scope changes). • Assist Director of Project Integration in preparing proposals and attend client meetings as needed. • Assist QA and Client Services with client visits and interactions as appropriate. • Develop new business by building successful client relationships. • Liaise with Quality Assurance regarding regulatory compliance of study conduct and Sponsor audits. • Write and update SOPs as required. • Perform other related duties as assigned.

Requisition ID: 63678BR

Job Category: Biotechnology/Pharmaceutical

Locations: Japan - Tokyo

Shift: 1

Job Postings: • A member of the leadership within the global Project Integration team with a particular focus on project management and signature client service delivery for projects with a CDARO component. • Responsibility for all aspects of administration, organization of the department, and has responsibility for the professional and personal development for all individuals within Project Integration. • Ensure all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical Practices. • Performs supervisory duties including but not limited to interviewing, hiring, training, intervention, discipline, and discharging of staff. • Coaches and mentors staff including initiating and implementing appropriate staff development programs. Meets with staff on a routine basis to review goals and individual development plans. • Motivates team to complete high quality work efficiently. • Schedules team workflow. Ensures that staff levels are adequate to meet the forecasted workload. Recommends changes if necessary and justifies them in accordance with company policy. • Ensures that appropriate training programs are in place so that staff is adequately and properly trained for their job requirements. • Ensures that all training files are up to date and complete in accordance with SOPs and ICH/GCP. • Assists in the review and amendment of departmental processes and supporting documentation. • Ensure that the highest levels of client service are maintained. • Serves as a Project Manager on assigned studies. • Identify specific Project Integration requirements from clients. • Coordinate Data Management, Programming, and Statistics projects, teams, and deadlines. • Communicate on a regular basis with assigned clients regarding questions, concerns, and project status. • Organize, chair, and record minutes for all project team meetings. • Facilitate meetings with Sponsors. • Ensure the relevant personnel are kept informed of problems that may affect the project performance. • Ensure all appropriate documentation and procedures are performed upon project completion. • Communicate with the Data Management, Programming, Statistics, Pharmacokinetics, Medical Writing, and QA departments regarding study progress and reporting requirements. • Update the Project Integration internal timelines for allocated projects in a timely manner. Renegotiate timelines as appropriate. • Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team. • Provide senior management with updates on timelines and projects. • Keep senior management and/or client services informed of pertinent project or client related information (i.e., work scope changes). • Assist Director of Project Integration in preparing proposals and attend client meetings as needed. • Assist QA and Client Services with client visits and interactions as appropriate. • Develop new business by building successful client relationships. • Liaise with Quality Assurance regarding regulatory compliance of study conduct and Sponsor audits. • Write and update SOPs as required. • Perform other related duties as assigned.

Education/Qualifications: BS or BSc in Science, Medical, or related field

• Knowledge/experience with drug development

• Knowledge/experience clinical research preferred

Experience: • Minimum of 5 years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical project management tasks and knowledge of CDARO-related activities

• In lieu of the above requirements, candidates with >5 years supervisory experience in a health care setting and 4 years clinical research experience in the pharmaceutical or CRO industries will be considered

EEO Statement:

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.