Do you have excellent leadership and people management skills? And sufficient experience as a CRA?
Are you ready for your next step in your Life Sciences career? Then this job is a great and not miss opportunity!
Job Description
The CRA Line Manager provides leadership in the delivery of services to the client, provides direct supervision and support to CRA's, to ensure performance, deliverables, and quality expectations are achieved for the clinical trials. The CRA Line Manager provides guidance and follow-up regarding the CRA's career development.
Responsibilities
- Support the screening, selection and the onboarding process of new hires.
- Evaluate CRA's performance through the Clients feedback and lead Performance Review Meetings with the CRA's
- Communicate with all internal stakeholders within Oxford Global Resources and act as a liaison between the Client and the deployed CRA team
- Review the time registration and expenses of the team on a monthly basis
- Evaluate the requirements of CRA resources, in collaboration with the client, in order to ensure continuity in the conduct of the clinical trials
- Be aware of current and forecasted resource capacity in his/her country
- Manage resources in a balanced way the clinical trials in a timely and efficient fashion whilst respecting the client's high standards
- Monitor and evaluate the CRA's workload and liaise with the Client, to ensure appropriate allocation of resources and optimal utilization of resources; manage conflicts between resources and work
- Ensure an appropriate backup is in place, when needed
- Identify (individual and group) training needs and support the development of a customized training program in collaboration with the client and the internal training department of Oxford Global Resources
- Provide support, mentoring and coaching to the CRA's to ensure their continuous development
- Coordinate training in cooperation with the Client and internal training department of Oxford Global Resources
- Organize CRA meetings in collaboration with the FSP trainer as a platform for training and experience sharing
- Discuss project-specific issues with the client
- Ensure compliance to ICH-GCP, the clients corporate policies, procedures, SOPs and quality standards and country specific regulatory requirements
- Perform in depth quality checks on process adherence and ensure deliverables are met through Functional Feedback Meetings on a regular basis and document actions and follow-up thereof
- Attend and provide input for different meetings in order manage and evaluate the quality oversight ( quarterly FSP Team meeting, monthly Functional Management Team meeting with the Client and /yearly operating review meeting with the Client)
- Perform accompanied site visits (on site and remotely) in accordance to the frequency schedule as defined by the client and document actions and follow-up thereof
- Write a monthly report to evaluate the compliance of the team to the Client KPI's and document actions and follow-up thereof
- Actively monitor the clients KPI's and take appropriate action to meet them
Profile
- At least a bachelor degree in a life science orientation or equivalent through experience.
- Previous CRA experience is mandatory.
- People management experience is desirable
- Collaboration
- Service-mindedness
- Adaptability
- Quality-minded
- Willingness to learn attitude
- Communication skills
- Problem-solving
- Result-orientation
- Leadership
- Developing & Coaching others
- Business Level of Dutch,French and English is required as a minimum
Benefits
- A balanced salary package based on your capabilities and experience, including meal vouchers, hospitalization and groups insurance, mobile phone, FIP-plan, etc ...
- Flexible between office and remote
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 17609
