Job title:
Manager, Clinical Monitoring (Remote, EU)
Company
Rho
Job description
Overview:Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.At Rho, you’ll have the opportunity to experience a thriving company with real stability – financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.We are currently hiring a Manager of Clinical Monitoring to join our team here at Rho! In this role, you will be responsible for the direct line management of clinical monitors to ensure optimal performance, career development, and retention of high performers. This role may support the implementation of Rho’s quality initiatives and business processes, achievement of management goals within the framework of the company’s core values, policies, and business practices.Our Clinical Operations Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group! Responsibilities:
- Direct report / functional management responsibilities for CRAs; meets routinely (at least twice monthly) with employees to provide mentorship and discuss development and performance
- For each direct report, maintains retrospective and prospective vigilance of utilization, realization, availability to take on additional work and paid time off
- Supports the assessment of clinical monitoring employee resources and employee resource projections to ensure that project teams meet client expectations and contractual obligations
- Reports monthly to manager on CRA staffing development progress, projections, gaps and potential needs, highlighting key areas of accomplishments, metrics and risks
- Supports the CRA Field Assessment process and associated procedural documents
- Performs periodic monitoring field assessment visits of CRAs to assess GCP/ICH knowledge and compliance in practice and to ensure continued level of optimal performance. Supplements assessments by proactively seeking input from appropriate project managers and CTLs as to project-specific performance
- Provides dynamic mentorship in all aspects of clinical monitoring; serves as escalation point and technical expert for employees and clients as needed
- Collaborates with project teams to ensure customer satisfaction, high quality deliverables, and profitability for all clinical monitoring projects
- Determines level and type of clinical monitoring employee resources needed to meet corporate/client/project objectives
- Interfaces with staff across projects and functional areas, providing input and feedback to promote quality deliverables
- May participate in client presentations and/or bid defense meetings as required
- May participate in Sponsor and Regulatory Authority audits as requested by Quality Assurance (QA)
- Ensures staff fulfills their responsibilities in accordance with policies, procedures, SOPs, ICH-GCPs, and regulatory requirements
- Participates in quality efforts for continuous improvement by assuring quality metrics are in line with company, client and clinical operations objectives
- Performs other duties per the guidance of manager and/or other leadership
Qualifications:
- Bachelors Degree along with a Minimum of 4 years clinical monitoring/management experience and 2 years of experience managing clinical monitors, either via direct line management or functional/project management
- Functional understanding of people management, project staffing, and typical CRA team structures
- Exhibits clear understanding of the drug development process
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Demonstrates effective decision-making skills
- Experience developing and mentoring staff
- Proven ability to balance competing priorities; ability to see patterns in issues, discount non-issues and prioritize to make progress
- Proactive and effective communicator
- Ability to identify issues within a project and lead the team to resolution
- Strategic thinker and active problem-solver
- Ability to bring order to situations that others may perceive as disjointed
- Ability to “get things done” in complex situations with minimal oversight
- Ability to travel up to 50%
- Experience within Rho’s main areas of therapeutic focus: Neurology/CNS/Psychiatry, Analgesia, Dermatology, and Respiratory.
Please submit your CV in English. Thank you!#LI-remote#clinicaloperations
Expected salary
Location
United Kingdom
Job date
Sat, 20 Jul 2024 01:05:56 GMT
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