Covance Associate Clinical Operation Manager in Beijing China, China

Job Description:

Covance's consistent growth, size, comprehensive drug development services offerings, and geographic spread give us the opportunity to build rewarding careers. We have global operations in more than 25 countries, and more than 11,000 employees worldwide.

Here, you can make a difference, not only by helping to deliver life-saving and life-enhancing medicines to people around the world, but also by helping us become a great company - one that delights our clients with the broadest and best service portfolio in our industry, energizes our people with a stimulating environment and growth

opportunities, and rewards our investors with outstanding returns

Covance is currently seeking a Clinical Operation Manager to start in Q3

People Responsibilities:

Direct Reports: Between 10 and 20 Clinical Operations Staff, dependent upon business need

Indirect Reports: None

Job Duties:

A. GCP and Quality Oversight:

• Has GCP oversight of direct reports by ensuring GCP training is executed, understood and implemented

• Identify and escalate GCP issues identified through regular interactions with direct reports and conduct of Accompanied Field Visits

• Ensures training record compliance with training matrix and ensures training records are up to date

• Provide input to relevant SOPs and standard plans/templates for use by Project Management and Clinical Operations staff

• Assist with on-boarding of new direct reports ensuring GCP training before monitoring begins

• Hold Clinical Operations staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate

• Hold Clinical Operations staff accountable for quality and compliance with project plan and adherence to contract obligations in Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables

• Coach Clinical Operations staff to own effective Investigator relations and Investigator oversight at the local level

B. Productivity and Financial Management:

• Communicate status of assigned workload for metric reporting

• Perform weekly review of direct report billable hours and associated utilization per the quarterly and annual budget plan, and escalation of outliers to management team for mitigation

• Escalates available workload hours, in context of project allocation, supply and demand, to management team

• Adheres to global tools for monitoring and utilization forecasting

• Engage in Resource management activities for direct reports

• Assist with staff recruitment through screening and interviewing

• Financial authority in accordance with current signature approval matrix

• Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports

• Liaise with internal and external customers in relevant process improvement initiatives, including Six Sigma

• Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity

• Schedule Accompanied Field Visits to ensure costs are in alignment with regional budget

Utilization of direct reports in conjunction with the Country Lead and Management Team

• List all essential external client-related job duties (if any)

B. Principal Contacts and Scope of Communications

• Clinical Operations Staff

• Country Lead

• Senior Directors

• Project Directors

• Project Managers

• Regulatory Department

• Quality Assurance Department

• Finance Department

• Human Resources Department

• Legal Department

Type of Communication Audience Frequency

Influence – Effect change without direct exercise of command where persuasion is required 1 Internal

0 External

1 Daily

0 Weekly

0 Monthly

0 Annually

Negotiate – Come to agreement through discussion and compromise – short to medium impact 1 Internal

0 External

1 Daily

0 Weekly

0 Monthly

0 Annually

Strategic – Manage communications of great importance having long term implications 1 Internal

0 External

0 Daily

0 Weekly

1 Monthly

0 Annually

C. Travel Requirements: Yes

• 30-50% travel by plane and car as required with overnight and domestic/potential international travel

• Ability to drive and have a valid driver’s license as appropriate per country travel norms

D. Language Skills Required:

• Speaking: Yes - English and Local Language required

• Writing/Reading: Yes - English and Local Language required

Requisition ID: 69500BR

Job Category: Clinical Research

Locations: China - Beijing, China - Guangzhou, China - Shanghai

Shift: 1

Job Postings: Covance's consistent growth, size, comprehensive drug development services offerings, and geographic spread give us the opportunity to build rewarding careers. We have global operations in more than 25 countries, and more than 11,000 employees worldwide.

Here, you can make a difference, not only by helping to deliver life-saving and life-enhancing medicines to people around the world, but also by helping us become a great company - one that delights our clients with the broadest and best service portfolio in our industry, energizes our people with a stimulating environment and growth

opportunities, and rewards our investors with outstanding returns

Covance is currently seeking a Clinical Operation Manager to start in Q3

People Responsibilities:

Direct Reports: Between 10 and 20 Clinical Operations Staff, dependent upon business need

Indirect Reports: None

Job Duties:

A. GCP and Quality Oversight:

• Has GCP oversight of direct reports by ensuring GCP training is executed, understood and implemented

• Identify and escalate GCP issues identified through regular interactions with direct reports and conduct of Accompanied Field Visits

• Ensures training record compliance with training matrix and ensures training records are up to date

• Provide input to relevant SOPs and standard plans/templates for use by Project Management and Clinical Operations staff

• Assist with on-boarding of new direct reports ensuring GCP training before monitoring begins

• Hold Clinical Operations staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate

• Hold Clinical Operations staff accountable for quality and compliance with project plan and adherence to contract obligations in Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables

• Coach Clinical Operations staff to own effective Investigator relations and Investigator oversight at the local level

B. Productivity and Financial Management:

• Communicate status of assigned workload for metric reporting

• Perform weekly review of direct report billable hours and associated utilization per the quarterly and annual budget plan, and escalation of outliers to management team for mitigation

• Escalates available workload hours, in context of project allocation, supply and demand, to management team

• Adheres to global tools for monitoring and utilization forecasting

• Engage in Resource management activities for direct reports

• Assist with staff recruitment through screening and interviewing

• Financial authority in accordance with current signature approval matrix

• Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports

• Liaise with internal and external customers in relevant process improvement initiatives, including Six Sigma

• Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity

• Schedule Accompanied Field Visits to ensure costs are in alignment with regional budget

Utilization of direct reports in conjunction with the Country Lead and Management Team

• List all essential external client-related job duties (if any)

B. Principal Contacts and Scope of Communications

• Clinical Operations Staff

• Country Lead

• Senior Directors

• Project Directors

• Project Managers

• Regulatory Department

• Quality Assurance Department

• Finance Department

• Human Resources Department

• Legal Department

Type of Communication Audience Frequency

Influence – Effect change without direct exercise of command where persuasion is required 1 Internal

0 External

1 Daily

0 Weekly

0 Monthly

0 Annually

Negotiate – Come to agreement through discussion and compromise – short to medium impact 1 Internal

0 External

1 Daily

0 Weekly

0 Monthly

0 Annually

Strategic – Manage communications of great importance having long term implications 1 Internal

0 External

0 Daily

0 Weekly

1 Monthly

0 Annually

C. Travel Requirements: Yes

• 30-50% travel by plane and car as required with overnight and domestic/potential international travel

• Ability to drive and have a valid driver’s license as appropriate per country travel norms

D. Language Skills Required:

• Speaking: Yes - English and Local Language required

• Writing/Reading: Yes - English and Local Language required

Education/Qualifications: Required:

• University/college degree – life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)

• In lieu of this required educational background the following relevant work history may be considered:

o Minimum of three (3) years supervisory experience in a health care or clinical research setting and

o Minimum of seven (7) years relevant clinical research experience in a pharmaceutical company/CRO

Preferred:

• Masters or other advanced degree

Experience: Required:

• Relevant clinical research experience in a pharmaceutical company or CRO

o Individual is proficient with on site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits)

o Minimum of five (5) years relevant clinical research experience in a pharmaceutical company/CRO

o Thorough knowledge of drug development process

o Thorough knowledge of relevant SOPs, ICH, and GCP guidelines

• Relevant supervisory experience

o Minimum of 1 year as a Line Manager or Project Manager required

o Demonstrated ability to lead by example and to encourage team members to seek solutions

o Proven interpersonal skills

o Demonstrated ability to successfully participate as a member of a project team

o Demonstrated ability to successfully manage multiple competing priorities

o Excellent planning and organizational skills

o Excellent oral, written and presentation skills

About Covance:

Covance is one of the world’s largest and most comprehensive drug development services companies, with more than 11,000 employees in 60 countries. We began operations Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region. Through our discovery, nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Why Covance?

At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.

We welcome your application and believe this decision may be the most rewarding career move you will ever make!

Keywords: Clinical Research Associate, Clinical Operations, Clinical Trials, China

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.