Manager, Clinical Operations

hace 9 meses

Buenos Aires, Argentina Novasyte A tiempo completo

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BASIC FUNCTIONS:
Works with Clinical Operations Management staff to ensure the successful management, performance, and career development of Lead Clinical Research Associates (CRAs) and Clinical Research Associates (CRAs). 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 Biotech clinical 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 for assigned Lead CRAs and CRAs (both office and regionally based) in the following areas:

- Plans career development of staff.
- Anticipates resource issues and plan remedial action.
- Communicates with the 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, CTM 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 CTM, Lead CRA and CRA 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.

Project Duties/Responsibilities:

- May serve as CTM for projects as directed.
- Assists CTMs with defining the scope of work with the clinical monitoring team.
- Assists CTMs with identifying changes in scope.
- Provides vacation coverage for CTMs as required.
- 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 pr

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