IQVIA MedTech specializes in clinical research for Medical Devices and In-Vitro Diagnostic (IVD) products.
IQVIA MedTech's focused expertise meets the growing needs of device Sponsors to justify product safety and effectiveness as well as reimbursement and adoption challenges due to increased scrutiny by regulators, end-users, and patients.
Works with Clinical Operations Management staff to ensure the successful management, performance, and career development of Lead Clinical Research Associates (CRAs) Clinical Research Associates (CRAs) and Clinical Trail Associates (CTAs). Provides training and consultation related to clinical operating activities in the conduct of clinical trial projects. Serves as a source of clinical research expertise for IQVIA MedTech/Biotech clinical staff. Contributes to, and participates in, the marketing of IQVIA MedTech/Biotech services. Assures compliance with Good Clinical Practices (GCPs), ICH, ISO 14155, MEDDEV, Standard Operating Procedures (SOPs), Working Practices (WPs), and policies and procedures set forth by IQVIA MedTech/Biotech and its clients.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Responsible for the following activities:
Clinical Staff Line Management Duties/Responsibilities:
- Line management for assigned Lead CRAs , CRAs and CTAs (both office and regionally based) in the following areas:
- Plans career development of staff.
- Anticipates resource issues and plan remedial action.
- Communicates with the Clinical Project Managers, CTMs and/or Lead CRA, as needed, to ensure correct monitoring resources per project.
- Liaise with Project Managers to ensure monitoring deliverables/targets are met, ensure project hours are met, ensure excessive total hours are noted and action taken as necessary.
- Ensures any project issues and results of discussions with Project Managers and are escalated appropriately.
- In coordination with the Director, Clinical Operations ensures proper allocation of Operations resources.
- Assesses training requirements for monitoring staff.
- Organizes appropriate training in liaison with the IQVIA Biotech e-process and Integration (Training) Department. Monitors and records subsequent performance to assess the effects of training on efficiency.
- Conducts field evaluation visits with staff at sites.
- Holds regular one-on-one meetings with staff to discuss performance.
- Writes and delivers performance appraisals.
- Reviews and approve time sheets and expense reports as required.
- Coach, train, and support direct reports:
- Provides staff with expert clinical research and therapeutic advice.
- Assists with organizing and conducting Lead CRA and CRA Staff Meetings at regular intervals.
- Addresses issues discovered at meetings.
- Maintains an awareness of company policies to effectively represent the company perspective to clinical staff.
- Identifies training needs and ensure staff participation during in-house training activities as required.
- Collaborates with Director, Clinical Operations to develop and administer an effective orientation/on-boarding process for new Lead CRA, CRA and CTA hires.
- Maintains awareness of overall development in the field of clinical research and ensures that staff remains current on clinical monitoring developments.
Clinical Operations Department Duties/Responsibilities:
- Assists Clinical Operations Management with review and revision of departmental SOPs, working practices, and policies.
- Assists Clinical Operations Management with interviewing and making hiring recommendations and/or decisions on new staff.
- Communicates staff increase and equipment needs to Director, Clinical Operations.
- Communicates staff training needs to Director, Clinical Operations.
- Assists Director, Clinical Operations to create and deliver new department initiatives, improvement plans or training
- Assists Director, Clinical Operations with development of strategic departmental goals which correlate with corporate goals and formalize departmental action plans to meet those goals.
- Assists in developing department budget and is accountable for the profit/loss and the overall financial performance of the Clinical department.
- Assists Director, Clinical Operations with Process Improvement Plans and other special projects as required by the department.
- Provides clinical management oversight of clinical projects to ensure consistent on-time completion of client deliverables and timely escalation and resolution of issues.
- Collaborates with other department and/or functional groups to ensure consistency of processes.
- Assists CTMs/CPMs with defining the scope of work with the clinical monitoring team.
- Assists CTMs/CPMs with identifying changes in scope.
- Provides clinical expertise to project team as needed.
Business Development Duties/Responsibilities:
- Participate in the development of the clinical portion of client proposals including preparation of clinical project budget and text.
- Preparation for and attendance at capabilities and bid defense meetings.
- Participate in marketing activities, client presentations, and proposal development.
- Participate in and/or attend professional and industry meetings as a representative of IQVIA MedTech/Biotech.
KNOWLEDGE, SKILLS & ABILITIES:
- Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management.
- 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 assessing and recommending specific solutions in clinical settings.
- Ability to mentor and train clinical staff.
- Understanding of basic data processing functions, including electronic data capture.
- Working knowledge of Word, Excel, and Power Point.
- Working knowledge of current ICH/GCP/ISO14155 guidelines and applicable country specific 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 (or equivalent) in a life sciences program or RN/BSN (or equivalent) with a minimum of 5 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 3 years as a Clinical Research Associate/Clinical Monitor, by preference in medical devices.
- 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 global/multi region trial management experience is required.
- Prior proposal development and bid defense participation is preferred.
- Prior budget development and management experience is preferred.
- Prior experience in electronic data capture (EDC) is preferred.
- Prior site management experience is required.
- Prior project team leadership/management is required.
- Prior vendor management experience is preferred.
- Prior experience in a Clinical 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 perform normal job duties.