Associate Director, Clinical Operations, Oncology - IQVIA Biotech

BASIC FUNCTIONS:

Responsible for the successful management, performance, and career development of Clinical Research Associates (CRAs) and Clinical Monitoring Assistants.  Staff may be office or regionally based.  Provides training and consultation related to clinical operating activities in the conduct of clinical trial projects.  Serves as a source of scientific and therapeutic expertise for IQVIA Biotech staff.  Contributes to, and participates in, the marketing of IQVIA Biotech services.  Assures compliance with Good Clinical Practices (GCPs), ICH, Standard Operating Procedures (SOPs), Working Practices (WPs), and policies and procedures set forth by IQVIA Biotech and its clients.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Clinical Staff Line Management Duties/Responsibilities:

• Line management of a group of clinical staff (both office and regionally based) in the following areas:
  • Monitors project hours and overall workloads:
    • Anticipate resource issues and plan remedial action.
    • Work with Director, Clinical Monitoring, in the allocation of monitoring resources.
    • Work with Clinical Trial Managers (CTMs) to ensure correct monitoring resources per project.
    • Liaise with Project Managers to ensure project hours are met and excessive total hours are noted and action taken as necessary. 
    • Make sure the Director, Clinical Monitoring, is aware of all project issues and results of discussions with Project Managers and CTMs.
    • Review and approve time sheets and expense reports as required.
• Appraises performance of direct reports:
  • Plan career development of staff. 
  • Assess training requirements for monitoring staff.
  • Organize appropriate training in liaison with the IQVIA Biotech e-process and Integration (Training) Department.  Monitor and record subsequent performance to assess the effects of training on efficiency.
  • Conduct monitoring assessment visits with staff at sites.
  • Hold regular one-on-one meetings with staff to discuss performance.
  • Write and conduct annual performance appraisals at year-end.
• Coaches, trains, and supports direct reports:
  • Provide staff with expert clinical research and therapeutic advice.
  • Organize and conduct clinical staff meetings at regular intervals.  Deal with issues raised at meetings.
  • Maintain an awareness of company policies so as to effectively represent the company perspective to clinical staff.
  • Identify training needs and ensure staff participation during in-house training activities as required.
  • Develop and administer an effective orientation/on-boarding process for new hires.
  • Maintain awareness of overall development in the field of clinical research and ensure that staff remains current on clinical monitoring developments.

Clinical Monitoring Department Duties/Responsibilities:

• Assist Director, Clinical Monitoring with review and revision of departmental SOPs, working practices, and policies.
• Interview and make hiring recommendations and/or decisions on new staff.
• Keep Director, Clinical Monitoring aware of needs for increases in staff and equipment.
• Keep Director, Clinical Monitoring apprised of staff training needs.

New Business Development Duties/Responsibilities:

• Participate in the development of the clinical portion of client proposals including the budget process.
• Participate in marketing activities, client presentations, and proposal development.

KNOWLEDGE, SKILLS & ABILITIES:

• Thorough knowledge of clinical research process.
• Strong communication skills (verbal and written) to express complex ideas.
• Excellent organizational and interpersonal skills.
• Positive attitude and ability to interact with all levels of staff.
• Ability to balance needs of the organization with needs of staff.
• Ability to protect confidential/sensitive information.
• Ability to manage multiple priorities within the department and across staff.
• Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings.
• Understanding of basic data processing functions, including electronic data capture.
• Working knowledge of current ICH/GCP guidelines and applicable regulations.
• Able to qualify for a major credit card.
• Valid driver’s license; ability to rent automobile.
• Willingness and ability to travel domestically and internationally as required.

MINIMUM RECRUITMENT STANDARDS:

• BS/BA/BSc Hons (or equivalent) in a life sciences program or RN/BSN (or equivalent) with a minimum of 8 years direct experience in clinical studies or equivalent level of education, training and experience. Understanding of the entire clinical research process mandatory. 
• Previous experience in personnel management within a clinical research environment preferred.
• At least 4 years as a Clinical Research Associate/Clinical Monitor, including at least 2 years as a successful Lead CRA/Clinical Trial Manager.
• Demonstrated ability to lead and motivate a group of clinical research personnel.
• Excellent organizational, communication (verbal and written), and interpersonal skills. 
• Ability to work independently, prioritize and function effectively within a matrix team environment. 
• Working knowledge of Word, Excel, and Power Point. 
• Prior experience in electronic data capture (EDC) s preferred.
• Prior experience in a Contract Research Organization (CRO) is preferred.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Ability to travel domestically and internationally up to 40%.
• Very limited physical effort required to

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.