Manager, Clinical Operations
il y a 1 semaine
**Core Accountabilities**:
The Manager, Clinical Operations has oversight and management responsibility for personnel within the department primarily for, but not limited to Clinical Research Associates (all experience levels) regardless of employment type. The Manager supports position recruitment, supervision, and development of staff as well as ensuring available resources are balanced with contracted obligations and corporate objectives. The Manager acts as a support for resource planning and supports implementation of process improvement for assigned area(s).
**Principal Responsibilities**:
Strategic
Assists with process improvement initiatives across operational unit and in alignment with the CRO to deliver efficiencies and benefits to customers.
Ensures compliance with regulations and industry quality standards and assurance of audit readiness; includes the development of suitable company SOPs and compliance with FDA, EMEA, country specific and ICH-GCP guidelines and representation during audits and inspections.
Leadership and Operational Management
Proactively line manage and develop Clinical Operations staff ensuring compliance with GCP ICH Guidelines and adherence to defined budget
Effectively communicates critical updates and changes with projects on a regular basis, acknowledges employee/project successes and addresses risks to delivery with a focus upon mitigation planning.
Maintains an awareness of company policies and can effectively represent the company perspective to staff.
Supports the development of internal clinical administrative processes, providing input into clinical systems requirements and assists with defining the work flow for systems utilized by assigned employees.
Uses strong communication skills and effective working relationships to ensure consistent quality of work amongst direct reports.
Provides regular reports and updates, as requested.
Performs Quality Assessment Visits for CRAs/Contract CRAs therefore ability to travel globally is required
Performs additional activities as directed by Senior Director, Clinical Operations.
Resourcing and Line Management
Participates in the selection and recruitment of suitable and qualified staff.
Reviews resource requirements to ensure projects are adequately resourced as per budget, including reconciliation with time entry
Assesses, revises, and improves training processes and requirements for assigned staff to meet changing needs.
Responsible for compensation planning and talent review for direct reports.
Coaches and develops staff for further advancement or enhanced skill development.
Conducts regular 1:1 meetings with staff to discuss performance and study status.
Reviews and approves time and expense entries for nonbillable items only.
Collaborates with Clinical Operations management to develop and administer an effective orientation/on-boarding process for new staff.
Additional
The above job description in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company. The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company.
**Essential Work Experience, Qualifications and Knowledge**:
Substantial experience in Clinical Operations, including CRA experience (in-house and/or on-site)
Extensive knowledge of ICH GCP guidelines and industry standards of quality.
Problem solving capabilities with strong attention to detail.
Relationship building skills and strong interpersonal presence.
Excellent written and verbal communication skills.
Ability to balance the needs of the organization with the needs of staff.
Demonstrated ability to lead and motivate a group of clinical research personnel.
Must be French and English speaking.
**Desirable Work Experience, Qualifications and Knowledge**:
Bachelor’s degree in a life science.
Strong motivational skills and understanding of customer service.
Positive attitude and ability to interact with all levels of staff.
Risk-Based Quality Management (RBQM) experience
**Cmed Core Values and Guiding Principles**:
All Cmed employees are required to exhibit and demonstrate the Cmed ‘Core Values’.
**Client focus**: Satisfaction and Solutions
**Dependability**: Competence and Quality
**Trustworthy**: Open and Honest
**Innovative**: Approaches
**Winners**: Win-Win
All Cmed employees are required to follow Cmed’s Guiding Principles:
We care about our customers, but are not afraid to say no or disagree
We only take on projects within our abilities to perform well
We always aim to do the right thing and approach every situation with good intentions
We pursue responsible profit and responsible growth, and spend money sensibly, as if our own
We believe organisation, management, governance and control are positive,
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